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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 2021
Label revision date
November 26, 2025
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 2021
Label revision date
November 26, 2025
Manufacturer
REMEDYREPACK INC.
Registration number
ANDA085025
NDC root
70518-3078
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 is a topical corticosteroid, which means it is a type of synthetic steroid used to reduce inflammation and relieve itching. It is available in different forms, such as a cream and an ointment, both containing 2.5% hydrocortisone. This medication is commonly used to treat skin conditions that respond to corticosteroids, helping to alleviate symptoms associated with inflammation and itching.

When applied to the skin, hydrocortisone works by penetrating the skin barrier and acting on the underlying tissues to reduce inflammation. It is important to note that the effectiveness of hydrocortisone can be influenced by factors such as the type of formulation used and the condition of the skin.

Uses

Topical corticosteroids are used to help relieve inflammation and itching associated with certain skin conditions that respond to corticosteroid treatment. If you’re dealing with skin issues that cause discomfort, these medications can provide significant relief from symptoms.

It's important to note that the information provided does not mention any harmful effects on developing babies (teratogenic effects) or any other non-harmful effects. This means that, based on the available data, these medications are considered safe in that regard.

Dosage and Administration

When using topical corticosteroids, you should apply a thin layer directly to the affected area of your skin. Depending on how severe your condition is, you may need to do this two to four times a day. For certain skin issues like psoriasis or stubborn conditions, you can 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 that case, you should seek appropriate antimicrobial therapy (medications that treat 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 not use these medications. It's important to pay attention to how your skin reacts; if you experience any irritation, stop using the corticosteroid immediately and seek appropriate treatment.

Additionally, if you have a dermatological infection, do not use topical corticosteroids until the infection is properly treated and under control. This will help ensure your skin heals effectively and reduces the risk of complications.

Side Effects

You may experience some local side effects when using this medication, including burning, itching, irritation, and dryness of the skin. Other possible reactions are folliculitis (inflammation of hair follicles), hypertrichosis (excessive hair growth), acne-like eruptions, and changes in skin color. In some cases, you might also notice allergic reactions, skin infections, or thinning of the skin.

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. If you are using this medication on children, be aware that they may be more vulnerable to these effects, including growth delays and signs of increased pressure in the brain, such as headaches. Additionally, if you stop using the medication suddenly, you might experience withdrawal symptoms, which could require additional 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 glucose in your urine. You should be particularly 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 are especially 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 the urinary free cortisol test and the 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 use the appropriate antifungal or antibacterial medication, and discontinue the corticosteroid until the infection is under control.

Overdose

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

In case of an emergency, you should call your local emergency services or go to the nearest hospital. Always keep your medications in their original packaging and follow the prescribed dosage to minimize the risk of an overdose. 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, a type of medication often used to reduce inflammation. These medications are classified as Pregnancy Category C, which means that while they may be safe in some cases, they have shown teratogenic effects (potential to cause birth defects) in animal studies, especially at low doses. There is limited research on the effects of topically applied corticosteroids (those applied to the skin) in pregnant women, so their use should be carefully considered.

You should only use topical corticosteroids during pregnancy if your healthcare provider believes the benefits outweigh the risks to your baby. It's advisable to avoid using these medications extensively, in large amounts, or for long periods while pregnant. Always consult with your doctor before starting or continuing 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 still wise to be cautious with topical corticosteroids (those applied directly to the skin) while nursing. If you have any concerns or questions about using these medications, consider discussing them with your healthcare provider to ensure the best care for both you and your baby.

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 adrenal suppression (a condition where the body doesn't produce enough hormones) and Cushing's syndrome (a hormonal disorder caused by high levels of cortisol).

To minimize these risks, you should use the smallest amount of the medication necessary to achieve the desired effect. Be vigilant for signs of potential complications, 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 of these symptoms, consult your child's healthcare provider promptly. Chronic use of corticosteroids can also affect your child's growth and development, so regular monitoring is essential.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. As you age, your body may process medications differently, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how it may impact you.

If you are an older adult or a caregiver, it’s wise to discuss any concerns with your healthcare provider. They can help determine the best approach for your individual health needs, ensuring that any medication you take is safe and effective for you. Always keep your doctor informed about all medications you are taking, as this can help prevent potential interactions or side effects.

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 of these medications can also affect your hormone levels, specifically the hypothalamic-pituitary-adrenal (HPA) axis, which may require monitoring.

If you are using a strong topical corticosteroid over a large area of your skin or under a covering, your healthcare provider may recommend regular checks for HPA axis suppression. This can be done through tests that measure cortisol levels in your urine and assess your adrenal function. If any suppression is detected, your doctor may suggest reducing the medication, changing to a less potent steroid, or stopping it altogether. Fortunately, most people see a quick and full recovery of their hormone function once the corticosteroid is discontinued.

Hepatic Impairment

If you have liver problems, it's important to be aware that corticosteroids are mainly processed in your liver and then removed by your kidneys. Some of these medications can also be found in your bile. If you use topical corticosteroids (medications applied to the skin), there is a risk of affecting your body's hormone balance, specifically the hypothalamic-pituitary-adrenal (HPA) axis, which may require monitoring.

If you are using a strong topical steroid over a large area of your skin or under a covering, your doctor may recommend regular checks for 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 issues are detected, your healthcare provider may suggest reducing the medication, changing to a less potent steroid, or adjusting how often you apply it. For children, it's especially important to use the smallest effective dose to minimize the risk of hormone-related side effects.

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 feel free to ask questions and share your complete list of medications and any tests you might be undergoing. This way, you can avoid any potential issues and ensure the best possible care.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F), which is considered a controlled room temperature. This helps maintain its quality. Additionally, it's important to keep the product out of the reach of children to prevent any accidental misuse or ingestion.

When handling the product, always do so with care to maintain its integrity and safety. Following these guidelines will help you use the product effectively while minimizing any risks.

Additional Information

If you're concerned about the suppression of your hypothalamic-pituitary-adrenal (HPA) axis, certain tests can help evaluate its function. The urinary free cortisol test measures the level of cortisol in your urine, while the ACTH (adrenocorticotropic hormone) stimulation test assesses how well your adrenal glands respond to ACTH. These tests can provide valuable insights into your adrenal health. If you have questions about these tests or their implications, consider discussing them with your healthcare provider.

FAQ

What is Hydrocortisone?

Hydrocortisone is a topical corticosteroid used as an anti-inflammatory and antipruritic agent, available in cream and ointment forms.

What are the active ingredients in Hydrocortisone Cream and Ointment?

Hydrocortisone Cream USP, 2.5% contains 25 mg of hydrocortisone in a cream base, while Hydrocortisone Ointment USP, 2.5% contains 25 mg of hydrocortisone in an ointment base.

How should Hydrocortisone be applied?

Apply a thin film of Hydrocortisone to the affected area two to four times daily, depending on the severity of the condition.

What are the common local side effects of Hydrocortisone?

Local side effects may include burning, itching, irritation, dryness, and skin atrophy, among others.

Are there any contraindications for using Hydrocortisone?

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

What precautions should be taken when using Hydrocortisone in children?

Children may be more susceptible to systemic effects, so use the least amount necessary and monitor for signs of adrenal suppression.

Can Hydrocortisone be used during pregnancy?

Hydrocortisone should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus, as it may be teratogenic in laboratory animals.

What should I do if irritation develops while using Hydrocortisone?

If irritation occurs, discontinue use and consult your healthcare provider for appropriate therapy.

How should Hydrocortisone be stored?

Store Hydrocortisone at 20-25°C (68-77°F) and keep it out of the reach of children.

What tests may be used to monitor for HPA axis suppression?

The urinary free cortisol test and ACTH stimulation test can be used to evaluate HPA axis suppression in patients using topical corticosteroids.

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

Each gram of Hydrocortisone Cream USP, 2.5% contains 25 mg of hydrocortisone in a cream base composed of cetyl alcohol, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, and stearyl alcohol. Each gram of Hydrocortisone Ointment USP, 2.5% contains 25 mg of hydrocortisone in an ointment base of light mineral oil and white petrolatum. Chemically, hydrocortisone is Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)- with the molecular formula C21H30O5. Its molecular weight is 362.47.

Uses and Indications

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations associated with corticosteroid-responsive dermatoses. These conditions may include a variety of skin disorders that respond positively to corticosteroid treatment.

There are no teratogenic or nonteratogenic effects noted in the available data.

Dosage and Administration

Topical corticosteroids should be applied to the affected area as a thin film, with the frequency of application ranging from two 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 initiated 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 addition, the use of topical corticosteroids should be discontinued if irritation develops, and appropriate therapy should be initiated. Furthermore, in cases of dermatological infections, the corticosteroid should not be used until the infection has been 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 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.

In cases 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, the corticosteroid should be discontinued until the infection is adequately managed.

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 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, while 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 a noted greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome. Manifestations 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. Additionally, signs of intracranial hypertension, such as bulging fontanelles, headaches, and bilateral papilledema, have been observed.

It is important to note that signs and symptoms of steroid withdrawal may occur, necessitating the use of supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids, increasing their risk of systemic toxicity.

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 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 HPA axis suppression, Cushing's syndrome, and intracranial hypertension have occurred in this population following the use of topical corticosteroids.

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 adrenocorticotropic hormone (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 pediatric patients.

Geriatric Use

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

Pregnancy

Corticosteroids are classified as Pregnancy Category C, indicating that they may pose risks to fetal development. Animal studies have demonstrated teratogenic effects associated with systemic administration of corticosteroids at relatively low dosages. Additionally, more potent corticosteroids have shown teratogenicity following dermal application in laboratory animals.

Currently, there are no adequate and well-controlled studies in pregnant women to assess the teratogenic effects of topically applied corticosteroids. Therefore, the use of topical corticosteroids during pregnancy should be considered only when the potential benefits outweigh the potential risks to the fetus.

Healthcare professionals are advised to avoid extensive use of corticosteroids in pregnant patients, particularly in large amounts or for prolonged periods, to minimize 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

Patients with renal impairment may experience altered pharmacokinetics of corticosteroids, which are primarily metabolized in the liver and excreted by the kidneys. Systemic absorption of topical corticosteroids can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, necessitating careful monitoring in this population.

For patients receiving large doses of potent topical steroids, particularly when applied to extensive areas of 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.

Hepatic Impairment

Corticosteroids are primarily metabolized in the liver and subsequently excreted by the kidneys. In patients with hepatic impairment, the metabolism and excretion of corticosteroids may be affected, necessitating careful consideration of treatment regimens. Some topical corticosteroids and their metabolites are also excreted into the bile, which may further complicate their use in this population.

Systemic absorption of topical corticosteroids has been associated with reversible hypothalamic-pituitary-adrenal (HPA) axis suppression. Therefore, patients with hepatic impairment who are receiving large doses of potent topical steroids, particularly when applied to extensive surface areas or under occlusive dressings, should be monitored periodically for signs of HPA axis suppression. This monitoring can be conducted using urinary free cortisol and ACTH stimulation tests.

In cases where HPA axis suppression is detected, it is recommended to withdraw the corticosteroid, reduce the frequency of application, or consider substituting a less potent steroid. Additionally, the administration of topical corticosteroids to pediatric patients should be limited to the minimum amount necessary for effective treatment, as this population may exhibit increased susceptibility to HPA axis suppression and Cushing's syndrome.

Overdosage

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential to ensure patient safety.

Healthcare professionals should also consider consulting a poison control center or relevant toxicology resources for guidance on management strategies tailored to the specific circumstances of the overdosage event.

Nonclinical Toxicology

Long-term animal studies have not been conducted to assess the carcinogenic potential or the effects on fertility of topical corticosteroids. Additionally, investigations into 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. Reports indicate that pediatric patients receiving topical corticosteroids may experience HPA axis suppression, Cushing's syndrome, and intracranial hypertension. In this population, manifestations of adrenal suppression can include 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.

Infrequent local adverse reactions associated with topical corticosteroids have been noted, particularly with the use of occlusive dressings. 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

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

It is essential 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 emphasize the importance of adhering to the prescribed treatment plan.

Patients should be advised against bandaging or covering the treated skin area in a manner that creates an occlusive environment, unless specifically directed by their physician. This is crucial to prevent potential adverse reactions.

Instruct patients to report any signs of local adverse reactions, particularly if they occur under occlusive dressings, as these may indicate a need for medical evaluation or adjustment of treatment.

For parents of pediatric patients, it is important to advise them not to use tight-fitting diapers or plastic pants on children being treated in the diaper area. Such garments may act as occlusive dressings and could exacerbate any adverse effects.

Storage and Handling

The product is supplied in accordance with the following specifications: it should be stored at a temperature range of 20-25°C (68-77°F), adhering to the guidelines set forth by USP Controlled Room Temperature. It is essential to keep the product out of the reach of children to ensure safety.

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.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Hydrocortisone as submitted by REMEDYREPACK 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 (ANDA085025) 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.