Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Hydrocortisone

Last content change checked dailysee data sync status

Active ingredient
Hydrocortisone 10–25 mg
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 2016
Label revision date
December 22, 2025
FDA Insert
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10–25 mg
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 2016
Label revision date
December 22, 2025
Manufacturer
ANI Pharmaceuticals, Inc.
Registration number
ANDA080706
NDC roots
62559-430, 62559-431
FDA Insert
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

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

Drug Overview

Hydrocortisone is a topical corticosteroid, which is a type of synthetic steroid used to reduce inflammation and relieve itching. It is commonly applied to the skin to treat various conditions that cause inflammation and itching, such as dermatitis and other skin disorders. Hydrocortisone works by being absorbed through the skin, where it helps to decrease the inflammatory response and alleviate discomfort.

Available in different strengths, such as 1% and 2.5% creams, hydrocortisone is specifically formulated to provide relief from the symptoms associated with corticosteroid-responsive skin conditions. By applying hydrocortisone cream, you can help manage the discomfort caused by these skin issues effectively.

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 the information provided does not mention any teratogenic effects (which are harmful effects on a developing fetus) or nonteratogenic effects, meaning that there are no known risks of these types associated with the use of topical corticosteroids. Always consult with your healthcare provider for personalized advice and treatment options.

Dosage and Administration

To use this medication effectively, apply a thin layer to the affected area of your skin. You should do this two to four times a day, depending on how severe your condition is. For certain skin issues like psoriasis or stubborn conditions, you can use occlusive dressings (coverings that keep the medication in place) to help manage your symptoms.

However, if you notice any signs of infection, such as increased redness, swelling, or pus, stop using the occlusive dressings immediately. In that case, it's important to seek appropriate treatment with antimicrobial therapy (medications that fight infections). Always follow these guidelines to ensure the best results from your treatment.

What to Avoid

If you have a history of hypersensitivity (allergic reactions) to any ingredients in topical corticosteroids, you should not use these medications. It's important to stop using them immediately if you experience any irritation and seek appropriate treatment for that irritation.

Additionally, if you have a skin infection, you should use the right antifungal or antibacterial treatment before applying topical corticosteroids. If you don't see improvement quickly, discontinue the corticosteroid until the infection is properly managed. Always prioritize your health and consult with a healthcare professional if you have any concerns.

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 sometimes lead to serious side effects, including suppression of your body's natural hormone production (HPA axis suppression), symptoms similar to Cushing’s syndrome, high blood sugar (hyperglycemia), and sugar in your urine (glucosuria). This risk increases if you use stronger steroids, apply them over large areas of skin, use them for a long time, or cover them with occlusive dressings (tight bandages). If you are using a potent steroid in large amounts or under a dressing, your doctor may recommend tests like the urinary free cortisol and ACTH stimulation tests to monitor your hormone levels.

If you notice any irritation while using the corticosteroid, stop using it and consult your doctor for alternative treatments. Additionally, if you have a skin infection, it's important to treat that with the right antifungal or antibacterial medication before continuing with the corticosteroid. If you don't see improvement quickly, stop using the corticosteroid until the infection is under control. In children, be especially cautious, as they may absorb more of the medication and be at higher risk for side effects. If you experience severe symptoms or signs of withdrawal after stopping the medication, seek emergency help or contact your doctor immediately.

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

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with the use of corticosteroids. These medications are classified as Pregnancy Category C, which means that while they may be necessary for certain conditions, their safety during pregnancy has not been fully established. Laboratory studies have shown that corticosteroids can cause birth defects (teratogenic effects) in animals, even at low doses, and more potent forms have shown similar risks when applied to the skin.

Due to the lack of adequate studies in pregnant women, topical corticosteroids should only be used if the potential benefits outweigh the risks to your baby. It's advisable to avoid using these medications extensively, in large amounts, or for long periods during pregnancy. Always consult your healthcare provider before using any medication to ensure the best outcome for 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 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 (which affects hormone production) and Cushing’s syndrome (a hormonal disorder), as well as increased pressure in the brain.

You should watch for signs of these issues, such as slowed growth, delayed weight gain, low cortisol levels, headaches, or bulging fontanelles (the soft spots on a baby’s head). To minimize risks, use the smallest amount of topical corticosteroid necessary to effectively treat your child's condition, and be cautious with long-term use, as it can impact their growth and development.

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, it’s important to consult with a healthcare provider before starting the medication. 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 issues, it's important to be aware that corticosteroids, which are often used to treat various conditions, are processed mainly in the liver and then eliminated by the kidneys. Some topical corticosteroids can also be found in bile. When using these medications, especially in large doses or over large areas of skin, you may need to be monitored for potential suppression of the hypothalamic-pituitary-adrenal (HPA) axis, a system that helps regulate hormones in your body.

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

Hepatic Impairment

If you have liver problems, it's important to be aware that corticosteroids are mainly processed in your liver and then removed from your body through your kidneys. Some topical corticosteroids can also be found in bile, which is produced by the liver. If you are using a strong topical steroid over a large area of your skin or under a covering, your doctor may need to monitor your hormone levels to check for a condition called hypothalamic-pituitary-adrenal (HPA) axis suppression. This can be done through specific tests that measure cortisol levels in your urine and how your body responds to stimulation.

If signs of HPA axis suppression are detected, your healthcare provider may suggest reducing the amount of the steroid you use, changing to a weaker steroid, or stopping the medication altogether. The good news is that if you stop using the corticosteroid, your hormone levels usually return to normal quickly. Always discuss any concerns with your healthcare provider to ensure your treatment is safe and effective.

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 lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20° to 25°C (68° to 77°F), which is considered a controlled room temperature according to the United States Pharmacopeia (USP). This temperature range helps maintain the integrity of the device.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components. By adhering to these guidelines, you can help ensure the product remains effective and safe for use.

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?

Hydrocortisone is a topical corticosteroid used as an anti-inflammatory and antipruritic agent, belonging to a class of primarily synthetic steroids.

How should I apply Hydrocortisone?

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

What are the common side effects of Hydrocortisone?

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

Are there any contraindications for using Hydrocortisone?

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

Can I use Hydrocortisone during pregnancy?

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

What should I do if I experience irritation while using Hydrocortisone?

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

Is Hydrocortisone safe for children?

Children may be more susceptible to systemic toxicity from topical corticosteroids, so administration should be limited to the least amount necessary for effective treatment.

How should I store Hydrocortisone?

Store Hydrocortisone at 20° to 25°C (68° to 77°F) to maintain its effectiveness.

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 is pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11β)-. Its molecular formula is C21H30O5, and it has a molecular weight of 362.47 g/mol. Hydrocortisone Cream USP is available in two strengths: 1% and 2.5%. Each gram of Hydrocortisone Cream USP, 1%, contains 10 mg of hydrocortisone USP in a cream base that includes purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate, and sorbic acid. Each gram of Hydrocortisone Cream USP, 2.5%, contains 25 mg of hydrocortisone USP in a similar cream base.

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 reported in the available data.

Dosage and Administration

The medication should be applied to the affected area as a thin film, with a frequency of two to four 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 therapeutic effect. However, if an infection occurs, 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 of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be initiated. If irritation develops, topical corticosteroids must be discontinued, and if a favorable response to the infection treatment does not occur promptly, the corticosteroid should be stopped 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. The risk of systemic absorption is heightened under specific conditions, including the use of more potent steroids, application over extensive body areas, prolonged treatment duration, and the use of occlusive dressings.

For patients receiving high doses of potent topical steroids applied to large surface areas or under occlusive dressings, periodic evaluation for signs of HPA axis suppression is recommended. This can be accomplished 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 transitioning to a less potent steroid. Notably, recovery of HPA axis function typically occurs promptly and completely following discontinuation of the corticosteroid. However, in rare instances, withdrawal symptoms may arise, necessitating the administration of supplemental systemic corticosteroids.

Particular caution should be exercised when prescribing topical corticosteroids to children, as they may absorb larger amounts relative to their body size, increasing their susceptibility to systemic toxicity. In cases where irritation occurs, the use of topical corticosteroids should be halted, and appropriate therapeutic measures should be initiated.

In the presence of dermatological infections, it is essential to implement suitable antifungal or antibacterial treatment. If there is no prompt improvement, the corticosteroid should be discontinued until the infection is adequately managed.

To monitor for potential HPA axis suppression, 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 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 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 risk cannot be ruled out. Animal studies have demonstrated that corticosteroids can be teratogenic when administered systemically at relatively low dosage levels. Additionally, more potent corticosteroids have shown teratogenic effects following dermal application in laboratory animals. However, there are no adequate and well-controlled studies in pregnant women to assess the teratogenic effects of topically applied corticosteroids.

Topical corticosteroids should be prescribed during pregnancy only if 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 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

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

Patients receiving large doses of potent topical steroids, especially when applied to extensive areas or under occlusive dressings, should be periodically evaluated for signs of HPA axis suppression. This evaluation can be conducted using urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is detected, it is advisable to consider withdrawing the corticosteroid, reducing the frequency of application, or substituting with a less potent steroid.

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

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism and excretion of corticosteroids, which are primarily metabolized in the liver and excreted by the kidneys. 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.

It is recommended that patients receiving a large dose of a potent topical steroid, particularly when applied to a large surface area or under an occlusive dressing, be evaluated periodically for signs of HPA axis suppression. This evaluation should include monitoring urinary free cortisol levels and conducting 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. Notably, recovery of HPA axis function is typically prompt and complete following the discontinuation of the corticosteroid. Therefore, careful monitoring and appropriate adjustments are essential for patients with compromised liver function to ensure safety and efficacy in treatment.

Overdosage

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on the clinical presentation.

For further guidance, healthcare professionals should refer to established protocols and consult relevant toxicology resources.

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

Local adverse reactions associated with topical corticosteroids have been reported infrequently, with an increased occurrence noted when occlusive dressings are used. 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.

In pediatric patients, there is a noted increased susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing’s syndrome, attributed to a larger skin surface area relative to body weight. Reports indicate that pediatric patients receiving topical corticosteroids may experience 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 lack of response to ACTH stimulation. Symptoms of intracranial hypertension may present as bulging fontanelles, headaches, and bilateral papilledema.

It is recommended that the administration of topical corticosteroids in pediatric patients be restricted to the minimum amount necessary to achieve an effective therapeutic outcome, as chronic corticosteroid therapy may adversely affect growth and development.

For reporting suspected adverse reactions, individuals are encouraged to contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Patient Counseling

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

It is important for healthcare providers to inform patients that this medication should not be used for any condition other than the one for which it was prescribed. Additionally, patients should be instructed that the treated skin area should not be bandaged or covered in a manner that creates an occlusive environment unless specifically directed by their physician.

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

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), in compliance with USP Controlled Room Temperature guidelines. Proper storage conditions are essential to maintain the integrity and efficacy of the product.

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 diagnostic tools in this assessment.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Hydrocortisone as submitted by ANI 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 (ANDA080706) 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.