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Hydrocortisone

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Active ingredient
Hydrocortisone 10 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 1976
Label revision date
July 1, 2024
FDA Insert
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 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 1976
Label revision date
July 1, 2024
Manufacturer
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Registration number
ANDA080693
NDC root
0168-0015
FDA Insert
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Hydrocortisone Cream USP, 1% is a topical corticosteroid that contains hydrocortisone, a medication used to relieve inflammation and itching associated with certain skin conditions. It is designed for external use only and is effective for treating various skin issues that respond to corticosteroids.

When applied to the skin, hydrocortisone cream can be absorbed through the skin barrier, especially when the skin is inflamed or when occlusive dressings are used. Once absorbed, it works similarly to corticosteroids taken by mouth, helping to reduce inflammation and alleviate discomfort.

Uses

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

It's important to note that there are no reported teratogenic effects (which means they do not cause birth defects) associated with these medications, making them a safer option for many individuals. Always consult with your healthcare provider to determine the best treatment for your specific skin condition.

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 two to three times a day, depending on how severe your condition is. For certain skin issues like psoriasis or stubborn conditions, you might also use occlusive dressings, which are coverings that help keep the medication 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 consult your healthcare provider, who may recommend appropriate antimicrobial therapy (medications that fight infections) to address the issue. Always follow your healthcare provider's instructions for the best results.

What to Avoid

You should avoid using topical corticosteroids if you have a history of hypersensitivity (allergic reactions) to any of the ingredients in the product. If you experience irritation while using these medications, stop using them immediately and seek appropriate treatment.

Additionally, if you have a skin infection, it's important to use the right antifungal or antibacterial medication first. Do not continue using the corticosteroid until the infection is properly managed and you see a positive response. Always prioritize your health and consult with a healthcare professional if you have any concerns.

Side Effects

You may experience some local side effects from 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 symptoms such as weight gain and high blood sugar. In children, there is a risk of more serious 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). If you notice any signs of steroid withdrawal, you may need additional corticosteroids. It's important to be aware that children may absorb more of the medication, increasing their risk of side effects.

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. This risk increases if you use strong steroids over large areas of skin, for long periods, or with occlusive dressings (coverings that trap moisture). If you notice any irritation, stop using the corticosteroid and seek appropriate treatment. If you have a skin infection, make sure to use the right antifungal or antibacterial medication, and stop the corticosteroid if you don’t see improvement quickly.

If you are using a strong topical steroid on a large area of your body or under a dressing, your doctor may want to monitor your hormone levels through specific tests, such as urinary free cortisol and ACTH stimulation tests. If these tests show signs of hormone suppression, your doctor may suggest reducing the steroid use or switching to a less potent option. Recovery from any hormone suppression is usually quick and complete once you stop the medication, but be aware that some people may experience withdrawal symptoms that could require additional treatment. Children are particularly at risk for these side effects, as they may absorb more of the medication relative to their body size.

Overdose

When you use topical corticosteroids (medications applied to the skin to reduce inflammation), it's important to know that they can sometimes be absorbed into your body in amounts that may lead to systemic effects (effects that impact the entire body). This means that even though you are applying the medication to your skin, it can still affect other parts of your body.

If you suspect an overdose, look for signs such as unusual changes in mood, weight gain, or increased thirst. If you notice any of these symptoms or feel unwell, it’s crucial to seek medical help immediately. Always consult your healthcare provider if you have concerns about your medication or its effects.

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. 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 concerns, it’s important to use topical corticosteroids during pregnancy only if the potential 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

If you are breastfeeding and considering the use of corticosteroids, it's important to know that while systemically administered corticosteroids (those taken by mouth or injection) do appear in breast milk, the amounts are generally not expected to harm your baby. However, the effects of topical corticosteroids (those applied directly to the skin) on breast milk are not well understood, as it is unclear if they can be absorbed into the bloodstream in significant amounts.

Given this uncertainty, it's wise to be cautious when using topical corticosteroids while nursing. Always consult with your healthcare provider to discuss the best options for your situation and 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 they may be more sensitive to these treatments than adults. This is due to their larger skin surface area relative to their body weight. In some cases, children can experience 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). Signs of these issues can include slowed growth, delayed weight gain, and low cortisol levels.

To minimize risks, you should use the smallest amount of topical corticosteroids necessary to effectively treat your child's condition. Prolonged use of these medications can also affect your child's growth and development. Always consult with your healthcare provider to ensure safe and appropriate use for your child.

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, which can affect how well they work and the potential for side effects.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any adjustments are needed based on individual health conditions and ensure that the treatment is safe and effective for older adults. Always prioritize open communication with your healthcare team about any concerns or questions you may have.

Renal Impairment

If you have kidney issues, it's important to understand how corticosteroids may affect you. These medications are mainly processed in the liver and then removed from your body through your kidneys. This means that if your kidneys are not functioning well, it could impact how your body handles these drugs.

Additionally, some topical corticosteroids and their breakdown products are eliminated through the bile, which is another pathway for your body to get rid of these substances. Always consult your healthcare provider for guidance on dosage adjustments and monitoring if you have renal impairment, as they can help ensure your treatment is safe and effective.

Hepatic Impairment

If you have liver problems, it's important to be aware that corticosteroids are mainly processed in your liver before being eliminated by your kidneys. Some topical corticosteroids and their breakdown products are also removed through bile. 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 potential issues with your body's hormone regulation, specifically looking for signs of HPA (hypothalamic-pituitary-adrenal) axis suppression. This can be assessed through tests that measure cortisol levels in your urine and how your body responds to stimulation.

Should any signs of HPA axis suppression occur, your healthcare provider may suggest reducing the amount of the steroid you use, changing to a less potent option, or stopping the medication altogether. Fortunately, if you do stop using the steroid, your body's hormone function typically returns to normal quickly and completely. Always consult your healthcare provider for personalized advice and monitoring.

Drug Interactions

It's important to talk to your healthcare provider about any medications you are using, especially if you are applying potent topical steroids over large areas of your skin or using them for a long time. These practices can increase how much of the medication your body absorbs, which may lead to potential side effects.

If you are using a strong topical steroid in this way, your doctor may recommend tests to check your body's hormone levels, specifically the urinary free cortisol test and the ACTH stimulation test. These tests help ensure that your body's hormone production is functioning properly and that there are no adverse effects from the medication. Always keep your healthcare provider informed about your treatments to ensure your safety and well-being.

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). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safety and compliance with local regulations.

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 information about your body's stress response and hormone levels. If you think you might need these evaluations, consider discussing them with your healthcare provider.

FAQ

What is Hydrocortisone Cream USP, 1% used for?

Hydrocortisone Cream USP, 1% is 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 two or three times a day, depending on the severity of your condition.

Are there any contraindications for using this cream?

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

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

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

Can I use Hydrocortisone Cream if I have a skin infection?

In the presence of dermatological infections, you should use an appropriate antifungal or antibacterial agent and discontinue the cream until the infection is controlled.

What are some common local adverse reactions to this cream?

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

What are the potential systemic adverse reactions?

Systemic adverse reactions may include reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria.

Is it safe to use Hydrocortisone Cream during pregnancy?

Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can Hydrocortisone Cream be used while breastfeeding?

Caution should be exercised when administering topical corticosteroids to nursing women, as it is not known if they can be absorbed into breast milk.

How should I store Hydrocortisone Cream?

Store the cream at a controlled room temperature between 15° to 30°C (59° to 86°F).

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 USP, 1% contains hydrocortisone, chemically designated as pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11ß)-, with a molecular formula of C21H30O5 and a molecular weight of 362.47. Each gram of the cream delivers 10 mg of hydrocortisone, USP, formulated in a base that includes glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, benzyl alcohol, potassium sorbate, lactic acid, and purified water.

Uses and Indications

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations associated with corticosteroid-responsive dermatoses.

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

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 three times daily, contingent upon the severity of the condition being treated.

For the management of psoriasis or other recalcitrant conditions, occlusive dressings may be utilized to enhance the efficacy of the treatment. However, it is imperative that if an infection develops, the use of occlusive dressings must be discontinued immediately, and appropriate antimicrobial therapy should 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 cases where irritation develops, the use of topical corticosteroids should be discontinued, and appropriate therapy should be initiated. The presence of dermatological infections necessitates the use of an appropriate antifungal or antibacterial agent. If a favorable response to treatment does not occur promptly, the corticosteroid should be discontinued until the infection is adequately controlled.

Warnings and Precautions

Systemic absorption of topical corticosteroids has been associated with reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, which may manifest as Cushing's syndrome, hyperglycemia, and glucosuria in certain patients. Factors that can enhance systemic absorption include the use of more potent steroids, application over extensive surface areas, prolonged treatment duration, and the use of occlusive dressings. Should irritation occur, the application of topical corticosteroids must be discontinued, and appropriate alternative therapy should be initiated.

In cases where dermatological infections are present, it is imperative to employ suitable antifungal or antibacterial agents. If there is no prompt favorable response, the corticosteroid treatment should be halted until the infection is adequately managed.

Patients receiving high doses of potent topical steroids, particularly when applied to large areas or under occlusive dressings, should undergo periodic evaluations for signs of HPA axis suppression. Recommended monitoring parameters include urinary free cortisol and ACTH stimulation tests. If evidence of HPA axis suppression is detected, it is advisable to withdraw the corticosteroid, reduce the frequency of application, or consider switching to a less potent steroid. Typically, recovery of HPA axis function occurs rapidly and completely following discontinuation of the corticosteroid. However, in rare instances, withdrawal symptoms may arise, necessitating the use of supplemental systemic corticosteroids.

It is important to note that children may absorb larger amounts of topical corticosteroids relative to their body size, rendering them more vulnerable to systemic toxicity.

For the assessment of HPA axis suppression, the following laboratory tests are recommended: urinary free cortisol test and ACTH stimulation test. Regular monitoring and appropriate adjustments in therapy are essential to ensure patient safety and efficacy of treatment.

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 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

Conditions that enhance systemic absorption of topical steroids include the use of more potent formulations, application over extensive surface areas, prolonged usage, and the incorporation of occlusive dressings.

Patients who are administered a high dose of a potent topical steroid, particularly when applied to large areas of the skin or under occlusive dressings, should undergo periodic evaluations for potential hypothalamic-pituitary-adrenal (HPA) axis suppression. Recommended assessments include the urinary free cortisol test and the ACTH stimulation test to monitor for signs of HPA axis suppression. Regular monitoring is advised to ensure patient safety and to adjust treatment as necessary based on test results.

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 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 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, 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 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 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. Healthcare professionals should carefully weigh the risks and benefits before prescribing these medications 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, with subsequent excretion occurring through the kidneys. Therefore, patients with renal impairment may experience altered pharmacokinetics due to reduced kidney function. It is important for healthcare professionals to consider potential dosing adjustments and to monitor these patients closely, as the excretion of corticosteroids and their metabolites may be affected. Additionally, some topical corticosteroids and their metabolites are excreted via the bile, which may provide an alternative pathway for elimination in patients with compromised renal function. Careful assessment and individualized treatment plans are recommended for this patient population to ensure safety and efficacy.

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 via the bile, careful consideration is warranted when treating this patient population.

For patients receiving a large dose of a potent topical steroid applied to extensive areas of the skin or under an occlusive dressing, periodic evaluation for evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression is recommended. This evaluation can be conducted using urinary free cortisol and ACTH stimulation tests.

In cases where HPA axis suppression is detected, it is advisable to consider withdrawing the corticosteroid, reducing the frequency of application, or substituting a less potent steroid. It is important to note that recovery of HPA axis function is typically prompt and complete following the discontinuation of the corticosteroid.

Monitoring and adjustments in therapy should be made with caution to ensure the safety and efficacy of treatment in patients with compromised liver function.

Overdosage

Topically applied corticosteroids have the potential to be absorbed in quantities sufficient to elicit systemic effects. Healthcare professionals should be aware that overdosage may occur, particularly with prolonged use or application over large surface areas.

In cases of suspected overdosage, it is essential to monitor the patient for potential systemic effects, which may include symptoms such as adrenal suppression, Cushing's syndrome, or other hormonal imbalances.

Management of corticosteroid overdosage primarily involves discontinuation of the topical agent and supportive care. In severe cases, particularly where adrenal suppression is suspected, further evaluation and appropriate interventions may be necessary to restore normal adrenal function. Regular follow-up and monitoring of the patient's clinical status are recommended to ensure recovery and to mitigate any long-term effects associated with overdosage.

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

Postmarketing experience has identified several local adverse reactions associated with the use of topical corticosteroids, particularly when occlusive dressings are employed. These reactions, although reported infrequently, 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 pediatric populations, there have been reports of hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension linked to the use of topical corticosteroids. Manifestations of adrenal suppression in children may present as linear growth retardation, delayed weight gain, low plasma cortisol levels, and an absence of response to ACTH stimulation. Symptoms of intracranial hypertension can include bulging fontanelles, headaches, and bilateral papilledema.

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. It is important to emphasize that patients must avoid contact with the eyes while using this medication.

Patients should be informed that they should not use this medication for any condition other than the one for which it was prescribed. Additionally, they should be cautioned against bandaging or otherwise covering the treated skin area in a manner that creates an occlusive environment, unless specifically directed by their physician.

Healthcare providers should encourage patients to report any signs of local adverse reactions, particularly if they occur under occlusive dressings. For parents of pediatric patients, it is crucial to advise them against using tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may act as occlusive dressings and could exacerbate any potential adverse effects.

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). Care should be taken to ensure that the product is kept within this temperature range to maintain its integrity and efficacy.

Additional Clinical Information

Clinicians may consider utilizing specific tests to evaluate hypothalamic-pituitary-adrenal (HPA) axis suppression in patients. The urinary free cortisol test and the ACTH stimulation test are recommended as potentially helpful assessments in this context.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Hydrocortisone as submitted by E. Fougera & Co. a division of Fougera Pharmaceuticals 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 (ANDA080693) 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

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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.