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Hydrocortisone

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Active ingredient
Hydrocortisone 25 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2002
Label revision date
July 1, 2020
FDA Insert
Prescribing information, PDF file
Active ingredient
Hydrocortisone 25 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
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 2002
Label revision date
July 1, 2020
Manufacturer
Actavis Pharma, Inc.
Registration number
ANDA089682
NDC root
0472-0337
FDA Insert
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Drug Overview

Hydrocortisone cream is a topical medication that belongs to a class of drugs known as corticosteroids, which are primarily synthetic steroids used to reduce inflammation and relieve itching. This cream contains hydrocortisone, a synthetic steroid that works by decreasing the immune response in the skin, helping to alleviate symptoms associated with various skin conditions.

You can use hydrocortisone cream to treat inflammatory and itchy skin conditions that respond to corticosteroids. It is designed for external use only and is effective in providing relief from the discomfort caused by these skin issues.

Uses

Topical corticosteroids are used to help relieve inflammation and itching associated with certain skin conditions that respond to corticosteroid treatment. These conditions, known as corticosteroid-responsive dermatoses, can cause discomfort and irritation, and using these medications can provide significant relief.

It's important to note that there are no reported teratogenic effects (which means they do not cause birth defects) or nonteratogenic effects (which refer to other types of harmful effects) associated with these medications. This makes them a safer option for managing skin issues when used as directed.

Dosage and Administration

When using topical corticosteroids, you should apply a thin layer directly to the affected area of your skin. This should be done 2 to 4 times a day, depending on how severe your condition is. For certain skin issues like psoriasis or stubborn conditions, you might use occlusive dressings (coverings that keep the medication in place) to enhance the treatment's effectiveness.

However, if you notice any signs of infection, it's important to stop using the occlusive dressings immediately. In such cases, you should seek appropriate antimicrobial therapy (medications that fight infections) to address the infection before continuing with your treatment. 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 of the ingredients in topical corticosteroids, you should avoid using these medications. It's important to be aware of this contraindication to ensure your safety and prevent any adverse reactions. Always consult with your healthcare provider if you have any concerns or questions about your medical history and the use of these treatments.

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 also notice skin thinning, stretch marks, or secondary infections.

Systemically, this medication can affect your body's hormone levels, potentially leading to conditions like Cushing’s syndrome, which can cause weight gain and other symptoms, as well as increased blood sugar levels. If you are using this medication for children, be aware that they may be more prone to these effects, including growth delays and increased pressure in the brain, which can manifest as headaches or bulging fontanelles (soft spots on a baby's head). It's important to monitor for signs of steroid withdrawal, which may require additional treatment.

Warnings and Precautions

Using topical corticosteroids can lead to some serious side effects, especially if used improperly. You should be aware that these medications can affect your body's hormone levels, potentially leading to conditions like Cushing’s syndrome (a hormonal disorder) or increased blood sugar levels. This risk is higher if you use strong steroids over large areas of skin, for long periods, or with occlusive dressings (coverings that trap moisture). Children are particularly vulnerable to these effects, as they may absorb more of the medication.

If you are using a potent topical steroid on a large area or under a dressing, your doctor may recommend regular tests, such as urinary free cortisol and ACTH stimulation tests, to check for hormone suppression. If you notice any irritation or if you develop a skin infection, stop using the corticosteroid and consult your doctor for appropriate treatment. If your symptoms do not improve quickly, it’s important to discontinue the steroid until the infection is under control. Remember, recovery from any hormone suppression is usually quick once the medication is stopped.

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 potential risks associated with taking any medication. If you suspect that you or someone else may have taken too much of a medication, look for signs such as unusual drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can do this by calling your local emergency number or going to the nearest hospital. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, when in doubt, it's better to err on the side of caution and get help.

Pregnancy Use

Corticosteroids, a type of medication often used to reduce inflammation, may pose risks during pregnancy. Studies in laboratory animals have shown that these drugs can cause birth defects (teratogenic effects) even at low doses when given systemically (throughout the body). Additionally, more potent corticosteroids have been linked to similar risks when applied to the skin. However, there are no well-controlled studies in pregnant women to confirm these effects from topical (skin-applied) corticosteroids.

Because of these potential risks, it is important to use topical corticosteroids during pregnancy only if the benefits outweigh the risks to your baby. You should avoid using these medications extensively, in large amounts, or for long periods while pregnant. Always consult your healthcare provider before using any medication during pregnancy to ensure the safety of both you and your baby.

Lactation Use

When using corticosteroids while breastfeeding, it's important to be aware of how they may affect you and your baby. While it is unclear if applying corticosteroids to the skin can lead to enough absorption into your bloodstream to appear in breast milk, systemic (taken into the body) corticosteroids are known to be present in breast milk in amounts that are unlikely to harm your infant.

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

Pediatric Use

When using topical corticosteroids (medications applied to the skin) for children, it's important to be aware that they may be more sensitive to side effects than adults. This is due to their larger skin surface area relative to their body weight. In some cases, children can experience serious conditions like adrenal suppression (a decrease in hormone production) and Cushing’s syndrome (a hormonal disorder), as well as increased pressure in the brain.

To minimize risks, you should use the smallest amount of the medication necessary to effectively treat your child's condition. Be vigilant for signs of potential side effects, such as slowed growth, delayed weight gain, low cortisol levels, headaches, or bulging fontanelles (the soft spots on a baby’s head). Long-term use of these medications can also affect your child's growth and development, so regular check-ups with your healthcare provider are essential.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert for Hydrocortisone Cream USP, 2.5% does not provide specific information about dosage adjustments or special monitoring for your condition. This means that there are no tailored guidelines or safety considerations mentioned for patients with renal impairment (kidney issues).

Before using this cream, it’s a good idea to consult your healthcare provider to discuss your kidney health and any potential risks. They can help ensure that you use the medication safely and effectively.

Hepatic Impairment

If you have liver problems, it's important to be aware that corticosteroids, including topical ones, are processed mainly by your liver. This means that their effects can be different for you compared to those with healthy liver function. When using potent topical corticosteroids, especially over large areas of skin or under a bandage, you may need regular check-ups to monitor for potential suppression of your body's hormone production (known as HPA axis suppression). This can be assessed through specific tests like urinary free cortisol and ACTH stimulation tests.

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, if you do stop using the corticosteroid, your hormone levels typically return to normal quickly. Always discuss your treatment plan with your doctor to ensure it’s safe and effective for your liver condition.

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 of your product, store it at a controlled room temperature between 15° to 30°C (59° to 86°F). It's important to keep it away from freezing temperatures, as freezing can damage the product.

When handling the product, make sure to maintain a clean environment to avoid contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the effectiveness of the product.

Additional Information

If you're concerned about the function of your adrenal glands, which are part of the hypothalamic-pituitary-adrenal (HPA) axis, certain tests can help evaluate their activity. The urinary free cortisol test measures the amount of cortisol (a hormone produced by the adrenal glands) in your urine, while the ACTH stimulation test assesses how well your adrenal glands respond to adrenocorticotropic hormone (ACTH). These tests can provide valuable information about your adrenal health.

FAQ

What is Hydrocortisone Cream USP 2.5% used for?

Hydrocortisone cream is a topical corticosteroid indicated for the relief of inflammatory and pruritic (itchy) manifestations of corticosteroid-responsive dermatoses.

How should I apply Hydrocortisone Cream?

Apply a thin film of the cream to the affected area 2 to 4 times daily, depending on the severity of your condition. Occlusive dressings may be used for certain conditions like psoriasis.

What are the possible side effects of using Hydrocortisone Cream?

Local side effects may include burning, itching, irritation, and dryness. Systemic effects can include reversible hypothalamic-pituitary-adrenal (HPA) axis suppression and hyperglycemia.

Is Hydrocortisone Cream safe to use during pregnancy?

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

Can children use Hydrocortisone Cream?

Yes, but children may absorb larger amounts of topical corticosteroids and be more susceptible to systemic toxicity, including HPA axis suppression and Cushing’s syndrome.

What should I do if I experience irritation while using the cream?

If irritation develops, discontinue use of the cream and consult your doctor for appropriate therapy.

How should I store Hydrocortisone Cream?

Store the cream at controlled room temperature between 15° to 30°C (59° to 86°F) and do not freeze.

Are there any contraindications for using Hydrocortisone Cream?

Yes, it is contraindicated in patients with a history of hypersensitivity to any of the components of the preparation.

Packaging Info

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

Packaging configurations for Hydrocortisone.
Details

FDA Insert (PDF)

This is the full prescribing document for Hydrocortisone, 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

Hydrocortisone cream contains the synthetic steroid hydrocortisone (Pregn-4-ene-3,20-dione, 11, 17, 21-trihydroxy-, (11ß)-). The molecular formula of hydrocortisone is C21H30O5, and its molecular weight is 362.46 g/mol. Each gram of the 2.5% cream contains 25 mg of hydrocortisone, USP. The cream base comprises cetyl alcohol, citric acid, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax, and citric acid solution and sodium citrate solution to adjust pH.

Uses and Indications

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations associated with corticosteroid-responsive dermatoses. These medications are effective in managing various skin conditions characterized by inflammation and itching.

There are no teratogenic or nonteratogenic effects associated with the use of topical corticosteroids as per the available data.

Dosage and Administration

Topical corticosteroids should be applied to the affected area as a thin film, with a frequency of 2 to 4 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 and to initiate appropriate antimicrobial therapy to address the infection.

Contraindications

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

Warnings and Precautions

Systemic absorption of topical corticosteroids has been associated with 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 susceptible 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. Recommended laboratory tests for this assessment include the urinary free cortisol test and the ACTH stimulation test. Should evidence of HPA axis suppression be detected, it is advisable to consider withdrawing the medication, reducing the frequency of application, or substituting with a less potent steroid. Typically, recovery of HPA axis function occurs promptly and completely upon discontinuation of the corticosteroid; however, in rare cases, signs and symptoms of steroid withdrawal may arise, necessitating the use of supplemental systemic corticosteroids.

In instances where irritation occurs, the use of topical corticosteroids should be discontinued, and appropriate therapeutic measures should be initiated. If a dermatological infection is present, it is essential to implement suitable antifungal or antibacterial treatment. Should there be no prompt favorable response, the corticosteroid should be halted until the infection is adequately managed.

For monitoring HPA axis suppression, healthcare professionals may find the urinary free cortisol test and ACTH stimulation test beneficial in evaluating the patient's condition.

Side Effects

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

Local adverse reactions are commonly reported and include burning, itching, irritation, and dryness of the skin. Other local effects may consist of folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae, and miliaria.

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

In pediatric populations, there is an increased risk of HPA axis suppression and Cushing’s syndrome. Additionally, children may experience intracranial hypertension, which can manifest as bulging fontanelles, headaches, and bilateral papilledema. Signs of adrenal suppression in children may include linear growth retardation, delayed weight gain, low plasma cortisol levels, and an absence of response to ACTH stimulation.

It is important to note that signs and symptoms of steroid withdrawal may occur, necessitating the use of supplemental systemic corticosteroids. Furthermore, children may absorb proportionally larger amounts of topical corticosteroids, making them more susceptible to systemic toxicity.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Hydrocortisone.
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 this population 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 pediatric patients 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 children.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Corticosteroids are generally considered teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Additionally, more potent corticosteroids have demonstrated teratogenic effects following dermal application in these animal studies. 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 used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is advised that drugs of this class not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time to minimize any potential adverse fetal outcomes.

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

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the drug insert for Hydrocortisone Cream USP, 2.5%. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

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. Due to the potential for systemic absorption of topical corticosteroids, there is a risk of reversible hypothalamic-pituitary-adrenal (HPA) axis suppression in this population.

For patients receiving large doses of potent topical steroids, particularly when applied to extensive surface areas or under occlusive dressings, periodic evaluation for evidence of 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.

Recovery of HPA axis function is typically prompt and complete following discontinuation of the corticosteroid. Given the potential for systemic effects from topically applied corticosteroids, careful monitoring is warranted in patients with compromised liver function to mitigate risks associated with systemic absorption.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient's characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical attention is warranted. Recommended actions include:

  1. Assessment: Conduct a thorough evaluation of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Initiate supportive measures as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Decontamination: If the overdose is recent and the patient is alert, consider activated charcoal administration, provided there are no contraindications.

  4. Specific Antidotes: If applicable, administer specific antidotes as per established protocols for the substance involved in the overdose.

  5. Monitoring: Continuous monitoring of the patient’s vital signs and clinical status is crucial to detect any deterioration promptly.

Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for guidance on managing specific overdose cases. Documentation of the incident and the management steps taken is also critical for ongoing patient care and legal considerations.

Nonclinical Toxicology

Corticosteroids are generally recognized as teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Additionally, more potent corticosteroids have demonstrated teratogenic effects following dermal application in these animals. However, there are no adequate and well-controlled studies in pregnant women regarding the teratogenic effects of topically applied corticosteroids. Consequently, the use of topical corticosteroids during pregnancy should be considered only when the potential benefits outweigh the potential risks to the fetus. It is advised that drugs within this class not be used extensively on pregnant patients, in large amounts, or for prolonged durations.

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

Postmarketing Experience

Systemic absorption of topical corticosteroids has been associated with reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, as well as manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. In pediatric populations, reports indicate that HPA axis suppression, Cushing’s syndrome, and intracranial hypertension may occur following the use of topical corticosteroids.

In children, manifestations of adrenal suppression have included linear growth retardation, delayed weight gain, low plasma cortisol levels, and an absence of response to ACTH stimulation. Symptoms of intracranial hypertension reported include bulging fontanelles, headaches, and bilateral papilledema.

Local adverse reactions associated with topical corticosteroids have been reported infrequently, though they may occur more frequently with the use of occlusive dressings. These reactions 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.

For the reporting of suspected adverse events, individuals are encouraged to contact Actavis at 1-888-838-2872 or the FDA at 1-800-FDA-1088, or visit http://www.fda.gov/medwatch for voluntary reporting of adverse reactions.

Patient Counseling

Patients should be instructed to use this medication strictly as directed by their physician, emphasizing that it is intended for external use only. They 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 one for which it was prescribed. Healthcare providers should reinforce this point to ensure proper usage.

Patients should be advised that the treated skin area must 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 effects.

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 receiving treatment in the diaper area. These garments can act as occlusive dressings, which may exacerbate skin reactions or interfere with the medication's effectiveness.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature ranging from 15° to 30°C (59° to 86°F). Freezing the product is strictly prohibited to maintain its integrity and efficacy. Proper handling and storage conditions are essential to ensure the product remains effective throughout its shelf life.

Additional Clinical Information

The evaluation of hypothalamic-pituitary-adrenal (HPA) axis suppression in patients may be supported by specific diagnostic tests. Clinicians may consider utilizing the urinary free cortisol test and the ACTH stimulation test to assess HPA axis function effectively. These tests can provide valuable insights into the adrenal response and overall endocrine health of subjects.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Hydrocortisone as submitted by Actavis Pharma, Inc.. 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 Hydrocortisone, 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 (ANDA089682) 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.