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Texacort

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Active ingredient
Hydrocortisone 25 mg/1 mL
Other brand names
Dosage form
Solution
Route
Topical
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2011
Label revision date
January 8, 2024
FDA Insert
Prescribing information, PDF file
Active ingredient
Hydrocortisone 25 mg/1 mL
Other brand names
Dosage form
Solution
Route
Topical
Prescription status
Rx (prescription)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2011
Label revision date
January 8, 2024
Manufacturer
Mission Pharmacal Company
Registration number
ANDA081271
NDC root
0178-0455
FDA Insert
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Texacort Topical Solution is a medication that contains hydrocortisone, a type of corticosteroid, which is primarily used to relieve inflammation and itching associated with certain skin conditions. This solution is specifically formulated to treat inflammatory and pruritic (itchy) manifestations of skin disorders that respond to corticosteroids.

When applied to the skin, Texacort works by reducing inflammation and alleviating discomfort. It is designed for topical use, meaning it is applied directly to the affected area, where it can be absorbed through the skin to provide relief.

Uses

Texacort Topical Solution 2.5% is designed to help relieve inflammation and itching associated with certain skin conditions that respond to corticosteroids. If you're dealing with skin issues that cause discomfort, this solution may provide the relief you need.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. Always consult with your healthcare provider for personalized advice and to ensure it's the right treatment for you.

Dosage and Administration

When using topical corticosteroids, you should apply a thin layer to the affected area three to four times a day, depending on how severe your condition is. This helps to reduce inflammation and relieve symptoms. For certain skin conditions like psoriasis or stubborn issues, you may also use occlusive dressings, which are coverings that help the medication work better by keeping it in contact with your skin.

However, if you notice any signs of infection, such as increased redness, swelling, or pus, you should stop using the occlusive dressings immediately. In that case, it's important to seek appropriate antimicrobial therapy (medications that fight infections) to address the infection effectively. Always follow your healthcare provider's instructions for the best results.

What to Avoid

If you have a history of hypersensitivity (allergic reactions) to any ingredients in topical corticosteroids, you should avoid using these medications. Additionally, if you experience irritation after applying a topical corticosteroid, stop using it immediately and seek appropriate treatment. It's also important to discontinue use if you do not see improvement in your skin condition, especially if you have a dermatological infection, until the infection is properly managed.

Side Effects

You may experience some local side effects when using this medication, such as burning, itching, irritation, and dryness of the skin. Other possible reactions include folliculitis (inflammation of hair follicles), acne-like eruptions, and changes in skin color. In some cases, you might notice skin thinning, stretch marks, or secondary infections. If you have a history of allergies, be aware that allergic contact dermatitis could also occur.

Systemically, this medication can affect your body's hormone levels, potentially leading to conditions like Cushing's syndrome, which may cause symptoms such as weight gain and high blood sugar. Children are particularly sensitive to these effects, with risks including growth delays and increased pressure in the brain. If you notice any signs of irritation or infection, it's important to stop using the medication and consult your healthcare provider for appropriate treatment.

Warnings and Precautions

Using topical corticosteroids can lead to some serious side effects, including potential suppression of your body's hormone production (known as HPA axis suppression), which can cause symptoms like Cushing's syndrome, high blood sugar, and sugar in your urine. You should be especially cautious if you are using strong steroids over large areas of your skin, for long periods, or with occlusive dressings (coverings that trap moisture). Children may absorb more of these medications and could be at greater risk for these effects.

If you are using a large dose of a potent topical steroid, it's important to have regular check-ups. Your doctor may recommend tests like the urinary free cortisol test or ACTH stimulation test to monitor your hormone levels. If you notice any irritation, stop using the corticosteroid and consult your doctor for alternative treatments. Additionally, if you have a skin infection, make sure to treat it with the appropriate antifungal or antibacterial medication before continuing with the corticosteroid. If you do not see improvement quickly, discontinue the steroid until the infection is under control.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with corticosteroids, which are a type of medication often used to reduce inflammation. These medications are classified as Pregnancy Category C, meaning that while they may be necessary for some conditions, their safety during pregnancy has not been fully established. Laboratory studies have shown that corticosteroids can cause birth defects (teratogenic effects) in animals, especially when used in high doses or for long periods.

Because there are no well-controlled studies in pregnant women regarding the use of topical corticosteroids (those applied to the skin), you should only use them if your healthcare provider believes the benefits outweigh the potential risks to your baby. It's advisable to avoid using these medications extensively, in large amounts, or for prolonged periods during your pregnancy. Always consult with your healthcare provider before starting or continuing any medication while pregnant.

Lactation Use

If you are breastfeeding and considering the use of corticosteroids, it's important to know that while it is unclear if applying these medications to your skin can lead to enough absorption into your bloodstream to affect your breast milk, systemic (taken into the body) corticosteroids do appear in breast milk in amounts that are unlikely to harm your baby.

However, it's wise to be cautious when using topical corticosteroids (medications applied to the skin) while nursing. Always consult with your healthcare provider to ensure the safety of both you and your infant.

Pediatric Use

When using topical corticosteroids (medications applied to the skin) for your child, it's important to be aware that children may be more sensitive to these treatments than adults. This is due to their larger skin surface area relative to their body weight. As a result, there is a risk of serious side effects, such as HPA axis suppression (a condition where the body’s hormone production is affected), Cushing's syndrome (a hormonal disorder), and increased pressure in the brain.

To minimize these risks, you should use the smallest amount of topical corticosteroid necessary to effectively treat your child's condition. Be vigilant for signs of potential side effects, which can include slowed growth, delayed weight gain, low cortisol levels, headaches, and bulging fontanelles (the soft spots on a baby’s head). If you notice any concerning symptoms, consult your child's healthcare provider promptly. Chronic use of these medications can impact your child's growth and development, so careful management is essential.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about how it may affect you or if any dosage adjustments are necessary. This means that the safety and effectiveness of the medication for elderly patients have not been clearly established.

If you are an older adult or a caregiver, it's important to consult with a healthcare professional before starting this medication. They can provide guidance tailored to your individual health needs and help ensure that you are using the medication safely.

Renal Impairment

If you have kidney issues, it's important to be aware that corticosteroids, which are often used to treat various conditions, are primarily processed in the liver and then excreted by the kidneys. Some topical corticosteroids can also enter the bile. When using these medications, especially in large doses or over large areas of skin, you may need to be monitored for potential suppression of the hypothalamic-pituitary-adrenal (HPA) axis, a system that helps regulate hormones in your body.

To check for HPA axis suppression, your healthcare provider may perform tests like urinary free cortisol and ACTH stimulation tests. If suppression is detected, your doctor might suggest reducing the medication, changing to a less potent steroid, or stopping the treatment altogether. Fortunately, most people recover quickly and completely from HPA axis suppression once the corticosteroid is discontinued, although some may experience withdrawal symptoms that could require additional corticosteroid treatment.

Hepatic Impairment

If you have liver problems, it's important to be aware that corticosteroids, which are medications often used to reduce inflammation, are mainly processed in the liver. Some of these medications can also affect your body's hormone levels, specifically the hypothalamic-pituitary-adrenal (HPA) axis, which helps regulate stress responses. If you're using a strong topical corticosteroid over a large area of your skin or under a bandage, your doctor may recommend regular monitoring to check for any signs of HPA axis suppression. This can be done through tests that measure cortisol levels in your urine and how your body responds to stimulation.

If any suppression is detected, your healthcare provider may suggest reducing the amount you use, changing to a less potent steroid, or stopping the medication altogether. Fortunately, most people see a quick and complete recovery of their hormone function once the corticosteroid is discontinued. However, in rare cases, you might experience withdrawal symptoms, which could require additional corticosteroid treatment. Always consult your healthcare provider for personalized advice and monitoring.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance and safety of your product, store it at a controlled room temperature between 15° to 30°C (59° to 86°F). This temperature range helps maintain the integrity of the device.

When handling the product, be sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and effectiveness.

Additional Information

You may undergo specific tests to assess your adrenal function, including the urinary free cortisol test and the ACTH (adrenocorticotropic hormone) stimulation test. The urinary free cortisol test measures the amount of cortisol, a hormone produced by your adrenal glands, in your urine over a 24-hour period. The ACTH stimulation test evaluates how well your adrenal glands respond to ACTH, which stimulates cortisol production. These tests can help your healthcare provider diagnose conditions related to adrenal function.

FAQ

What is Texacort Topical Solution used for?

Texacort Topical Solution 2.5% is indicated for the relief of inflammatory and pruritic (itchy) manifestations of corticosteroids-responsive dermatoses.

What is the active ingredient in Texacort Topical Solution?

The active ingredient in Texacort Topical Solution is hydrocortisone.

How should Texacort Topical Solution be applied?

Topical corticosteroids like Texacort should be applied as a thin film to the affected area three to four times daily, depending on the severity of the condition.

Are there any contraindications for using Texacort Topical Solution?

Yes, Texacort is contraindicated in patients with a history of hypersensitivity to any of its components.

What are some common local adverse reactions to Texacort?

Common local adverse reactions may include burning, itching, irritation, dryness, and acneiform eruptions.

What precautions should be taken when using Texacort in children?

Children may be more susceptible to systemic effects like HPA axis suppression and Cushing's syndrome, so use should be limited to the least amount necessary for effective treatment.

Can Texacort be used during pregnancy?

Texacort should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as there are no adequate studies in pregnant women.

What should you do if irritation develops while using Texacort?

If irritation develops, you should discontinue the use of Texacort and institute appropriate therapy.

How should Texacort be stored?

Texacort should be stored at a controlled room temperature of 15° to 30°C (59° to 86°F).

Packaging Info

The table below lists all NDC Code configurations of Texacort (hydrocortisone), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Texacort.
Details

FDA Insert (PDF)

This is the full prescribing document for Texacort, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.

View FDA-approved insert (PDF)

Description

Texacort Topical Solution contains hydrocortisone as the active corticosteroid, with the chemical formula Pregn-4-ene-3, 20-dione, 11,17,21-trihydroxy-, (11 β)-. The molecular weight of hydrocortisone is 362.47, and its empirical formula is C21H30O5. Each milliliter of the solution contains 25 mg of hydrocortisone (2.5% W/V) in a specially formulated vehicle that includes alcohol (48.8% W/W), purified water, polysorbate 20, and isoceteth-20.

Uses and Indications

Texacort Topical Solution 2.5% is indicated for the relief of the inflammatory and pruritic manifestations associated with corticosteroids-responsive dermatoses.

There are no teratogenic or nonteratogenic effects reported for this medication.

Dosage and Administration

Topical corticosteroids should be applied to the affected area as a thin film, with a frequency of three to four times daily, depending on the severity of the condition being treated. For patients with psoriasis or other recalcitrant conditions, occlusive dressings may be utilized to enhance the efficacy of the treatment.

In cases where an infection develops, it is imperative to discontinue the use of occlusive dressings immediately. Appropriate antimicrobial therapy should then be instituted to address the infection.

Contraindications

Topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of the preparation.

In cases where irritation develops, the use of topical corticosteroids should be discontinued, and appropriate therapy should be initiated. Additionally, if a favorable response is not observed promptly in the presence of dermatological infections, the corticosteroid should be discontinued until the infection is adequately controlled.

Warnings and Precautions

Systemic absorption of topical corticosteroids can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, as well as manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in certain patients. Factors that may enhance systemic absorption include the use of more potent steroids, application over extensive surface areas, prolonged treatment duration, and the use of occlusive dressings. It is important to note that children may absorb larger amounts of topical corticosteroids relative to their body size, making them more vulnerable to systemic toxicity.

Patients receiving high doses of potent topical steroids, particularly when applied to large areas of the body or under occlusive dressings, should undergo periodic evaluations for signs of HPA axis suppression. This can be assessed through urinary free cortisol and ACTH stimulation tests. Should evidence of HPA axis suppression be detected, it is advisable to consider withdrawing the medication, reducing the frequency of application, or switching to a less potent steroid. Typically, recovery of HPA axis function occurs promptly and completely upon discontinuation of the corticosteroid; however, in rare cases, withdrawal symptoms may arise, necessitating the use of supplemental systemic corticosteroids.

In instances where irritation occurs, the use of topical corticosteroids should be halted, and appropriate alternative therapies should be initiated. Additionally, if dermatological infections are present, it is essential to implement suitable antifungal or antibacterial treatments. Should there be no prompt improvement in the infection, the corticosteroid should be discontinued until adequate control of the infection is achieved.

For monitoring purposes, the following laboratory tests are recommended: urinary free cortisol test and ACTH stimulation test.

Side Effects

Patients may experience a range of local and systemic adverse reactions associated with the use of this medication.

Local adverse reactions are common and may include burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. In cases where irritation develops, it is recommended that topical corticosteroids be discontinued and appropriate therapy instituted.

Systemic adverse reactions, while less frequent, can be serious. These may include reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria.

Pediatric patients are particularly susceptible to adverse reactions, including greater risks of topical corticosteroid-induced HPA axis suppression and Cushing's syndrome. Specific manifestations of adrenal suppression in this population may include linear growth retardation, delayed weight gain, low plasma cortisol levels, and an absence of response to ACTH stimulation. Additionally, signs of intracranial hypertension, such as bulging fontanelles, headaches, and bilateral papilledema, may also occur.

It is important to note that signs and symptoms of steroid withdrawal may arise, necessitating the use of supplemental systemic corticosteroids. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be initiated. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection is adequately controlled.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

The table below lists all NDC Code configurations of Texacort (hydrocortisone), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Texacort.
Details

Pediatric Use

Pediatric patients may exhibit increased susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome compared to mature patients, primarily due to a larger skin surface area relative to body weight. Reports indicate that children receiving topical corticosteroids have experienced HPA axis suppression, Cushing's syndrome, and intracranial hypertension.

Manifestations of adrenal suppression in pediatric patients can include linear growth retardation, delayed weight gain, low plasma cortisol levels, and a lack of response to ACTH stimulation. Additionally, signs of intracranial hypertension may present as bulging fontanelles, headaches, and bilateral papilledema.

To mitigate these risks, the administration of topical corticosteroids in children should be restricted to the minimum amount necessary to achieve an effective therapeutic outcome. It is important to note that chronic corticosteroid therapy may adversely affect the growth and development of pediatric patients.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments or safety concerns. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to closely monitor these patients for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Corticosteroids are classified as Pregnancy Category C, indicating that risk cannot be ruled out. Animal studies have demonstrated that corticosteroids can be teratogenic when administered systemically at relatively low dosages. Additionally, more potent corticosteroids have shown teratogenic effects following dermal application in laboratory animals. However, there are no adequate and well-controlled studies in pregnant women to assess the teratogenic effects of topically applied corticosteroids.

Given the potential risks, topical corticosteroids should be utilized during pregnancy only when the anticipated benefits outweigh the potential risks to the fetus. It is advised that drugs within this class not be used extensively, in large amounts, or for prolonged periods in pregnant patients. Healthcare professionals should carefully consider these factors when prescribing corticosteroids to women of childbearing potential.

Lactation

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. However, systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the breastfed infant.

Caution should be exercised when topical corticosteroids are administered to lactating mothers.

Renal Impairment

Corticosteroids are primarily metabolized in the liver and subsequently excreted by the kidneys. In patients with renal impairment, systemic absorption of topical corticosteroids may lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, necessitating careful monitoring.

For patients receiving large doses of potent topical steroids applied to extensive areas of the skin or under occlusive dressings, periodic evaluation for HPA axis suppression is recommended. This can be assessed through urinary free cortisol and ACTH stimulation tests. Should HPA axis suppression be detected, it is advisable to consider withdrawing the corticosteroid, reducing the frequency of application, or substituting with a less potent steroid.

Typically, recovery of HPA axis function occurs promptly and completely following discontinuation of the corticosteroid. However, in rare instances, patients may experience signs and symptoms of steroid withdrawal, which may require the administration of supplemental systemic corticosteroids.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism and excretion of corticosteroids, which are primarily metabolized in the liver and excreted by the kidneys. Given that some topical corticosteroids and their metabolites are also excreted into the bile, caution is advised when administering these medications to this patient population.

Systemic absorption of topical corticosteroids can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression. Therefore, it is essential to monitor patients with hepatic impairment for signs of HPA axis suppression, particularly those receiving large doses of potent topical steroids applied to extensive surface areas or under occlusive dressings. Periodic evaluations should include urinary free cortisol and ACTH stimulation tests to assess HPA axis function.

In cases where HPA axis suppression is detected, it is recommended to consider withdrawing the corticosteroid, reducing the frequency of application, or substituting a less potent steroid. Recovery of HPA axis function is typically prompt and complete following discontinuation of the corticosteroid. However, in rare instances, patients may experience signs and symptoms of steroid withdrawal, which may necessitate the administration of supplemental systemic corticosteroids.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate supportive care in the event of an overdose.

Nonclinical Toxicology

Long-term animal studies have not been conducted to assess the carcinogenic potential or the effects on fertility of topical corticosteroids. Additionally, studies evaluating the mutagenicity of prednisolone and hydrocortisone have demonstrated negative results.

Postmarketing Experience

Systemic absorption of topical corticosteroids has been associated with reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Factors that may enhance systemic absorption include the use of more potent steroids, application over large surface areas, prolonged use, and the use of occlusive dressings.

Patients receiving high doses of potent topical steroids, particularly when applied to extensive areas or under occlusive dressings, should be periodically evaluated for signs of HPA axis suppression. This evaluation can be conducted using urinary free cortisol and ACTH stimulation tests. In cases where HPA axis suppression is identified, it is recommended to withdraw the drug, reduce the frequency of application, or switch to a less potent steroid. Recovery of HPA axis function is typically prompt and complete following discontinuation of the drug; however, in rare instances, signs and symptoms of steroid withdrawal may necessitate the use of supplemental systemic corticosteroids.

Reports have indicated that HPA axis suppression, Cushing's syndrome, and intracranial hypertension can occur in children treated with topical corticosteroids. Manifestations of adrenal suppression in this population may include linear growth retardation, delayed weight gain, low plasma cortisol levels, and lack of response to ACTH stimulation. Symptoms of intracranial hypertension may present as bulging fontanelles, headaches, and bilateral papilledema.

Infrequent local adverse reactions associated with topical corticosteroids have been reported, with a potential increase in incidence when occlusive dressings are used. These reactions may include burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

Patient Counseling

Healthcare providers should advise patients that this medication is to be used strictly as directed by their physician and is intended for external use only. Patients must be cautioned to avoid contact with the eyes to prevent irritation or injury.

It is important for patients to understand that this medication should not be used for any condition other than the specific disorder for which it was prescribed. Providers should emphasize the necessity of following the prescribed treatment plan closely.

Patients should also be informed that the treated skin area should not be bandaged or covered in a manner that creates an occlusive environment unless specifically directed by their physician. This is crucial to prevent potential adverse reactions.

Healthcare providers should encourage patients to report any signs of local adverse reactions, particularly if they occur under occlusive dressings, as these may indicate a need for reevaluation of the treatment.

For parents of pediatric patients, it is essential to advise against the use of tight-fitting diapers or plastic pants on children being treated in the diaper area. Such garments may act as occlusive dressings, which could lead to increased risk of adverse effects.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature ranging from 15° to 30°C (59° to 86°F). Care should be taken to ensure that the storage environment maintains these temperature conditions to preserve the integrity of the product.

Additional Clinical Information

Patients may undergo a urinary free cortisol test and an ACTH stimulation test as part of the diagnostic process. These tests are utilized to assess adrenal function and cortisol levels, providing clinicians with essential information for evaluating conditions related to adrenal insufficiency or hypercortisolism.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Texacort as submitted by Mission Pharmacal Company. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Texacort, retrieved by a validated AI data-extraction workflow.

All FDA-approved dosage forms and strengths are listed in the Packaging & NDC Codes section above. Regulatory status, pharmacologic class (EPC), and mechanism of action (MoA) were cross-checked against the FDA Orange Book (ANDA081271) and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.