Quick answers
- What is Hydrocortisone used for?
- The FDA-approved label (Cortef, Pharmacia & Upjohn Company LLC, February 17, 2025) says: “CORTEF Tablets are indicated in the following conditions. 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Hydrocortisone have a boxed warning?
- No. None of the 99 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Hydrocortisone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Hydrocortisone been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started October 1, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Hydrocortisone?
- 45 companies list prescription products of Hydrocortisone in the FDA NDC Directory, including Bryant Ranch Prepack, Pharmacia & Upjohn Company LLC and ANI Pharmaceuticals, Inc..
What Hydrocortisone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CORTEF Tablets are indicated in the following conditions. 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable …
— FDA label: Cortef, Pharmacia & Upjohn Company LLC, effective February 17, 2025. Read the full label on DailyMed →
The FDA has 99 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 99 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Cream · Tablet · Ointment · Injection, powder, for solution · Lotion · Granule · Solution · Injection · Suspension · Enema |
|---|---|
| Route | Topical · Oral · Intramuscular · Intravenous · Rectal |
| Prescription products | 137 in the FDA NDC Directory |
| Brand names | Solu-Cortef, Proctozone-Hc, Alkindi Sprinkle, Cortef, Procto-Med Hc, Alacort, Proctosol-Hc, Ala-Scalp, Hydrocortisone Rectal Suspension (Retention), Khindivi, Cortenema, Anusol Hc |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| hydrocortisone 1% cream | Generic | $0.1050–$0.6186 per gram 3 packages, lowest to highest |
| hydrocortisone 1% ointment | Generic | $0.1368–$0.1565 per gram 2 packages, lowest to highest |
| hydrocortisone 10 mg tablet | Generic | $0.1827 per tablet |
| hydrocortisone 10 mg tablet | Brand: Cortef | $1.62 per tablet |
| hydrocortisone 100 mg/60 mL enema | Generic | $0.1433 per mL |
| hydrocortisone 100 mg/60 mL suspension | Generic | $0.1433 per mL |
| hydrocortisone 2.5% cream | Generic | $0.0827–$0.2366 per gram 8 packages, lowest to highest |
| hydrocortisone 2.5% cream | Brand: Proctosol-HC | $0.6984 per gram |
| hydrocortisone 2.5% ointment | Generic | $0.0660–$0.1215 per gram 3 packages, lowest to highest |
| hydrocortisone 20 mg tablet | Generic | $0.2991 per tablet |
| hydrocortisone 25 mg/mL lotion | Generic | $0.2157–$0.2358 per mL 2 packages, lowest to highest |
| hydrocortisone 25 mg/mL solution | Brand: Texacort | $6.22 per mL |
| hydrocortisone 5 mg tablet | Generic | $0.1392 per tablet |
| hydrocortisone 5 mg tablet | Brand: Cortef | $0.9751 per tablet |
| hydrocortisone sodium succinate 100 mg/2 mL injection | Generic | $14.46 per unit |
| hydrocortisone sodium succinate 100 mg/2 mL injection, powder, for solution | Generic | $14.46 per unit |
| hydrocortisone sodium succinate 100 mg/2 mL injection, powder, for solution | Brand: Solu-Cortef | $24.68–$25.73 per unit 3 packages, lowest to highest |
| hydrocortisone sodium succinate 250 mg/2 mL injection, powder, for solution | Brand: Solu-Cortef | $51.43 per unit |
NADAC list of November 4, 2026; these prices took effect between July 1, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack26 products
- Pharmacia & Upjohn Company LLC8 products
- ANI Pharmaceuticals, Inc.7 products
- A-S Medication Solutions5 products
- Preferred Pharmaceuticals Inc.5 products
- Eton Pharmaceuticals, Inc.5 products
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC4 products
- Direct_Rx4 products
- NuCare Pharmaceuticals, Inc.4 products
- Chartwell RX, LLC4 products
- Crown Laboratories4 products
- Solco Healthcare LLC3 products
- Padagis Israel Pharmaceuticals Ltd3 products
- Strides Pharma Inc.3 products
- Aurobindo Pharma Limited3 products
- Mylan Pharmaceuticals Inc.3 products
- Amneal Pharmaceuticals of New York LLC3 products
- Eywa Pharma Inc3 products
- AvPAK3 products
- Strides Pharma Science Limited3 products
- Proficient Rx LP3 products
- PD-Rx Pharmaceuticals, Inc.3 products
- Sportpharm LLC2 products
- Asclemed USA, Inc.2 products
- Sun Pharmaceutical Industries, Inc.2 products
- American Health Packaging2 products
- HF Acquisition Co LLC, DBA HealthFirst2 products
- Leading Pharma, LLC1 product
- Remedyrepack Inc.1 product
- Major Pharmaceuticals1 product
- Derm Ventures LLC1 product
- Rising Pharma Holdings, Inc.1 product
- Actavis Pharma, Inc.1 product
- Trifluent Pharma, LLC1 product
- Salix Pharmaceuticals, Inc.1 product
- Encube Ethicals, Inc.1 product
- Allegis Holdings LLC1 product
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 product
- Mission Pharmacal Company1 product
- Cardinal Health 107, LLC1 product
- ProPharma Distribution1 product
- Apotex Corp.1 product
- Zydus Pharmaceuticals USA Inc.1 product
- Zydus Lifesciences Limited1 product
- Cipla USA Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA008697 CORTEF | Pharmacia and Upjohn | December 15, 1952 | 10, latest June 5, 2024 2024: Labeling · 2023: Labeling · 2019: Labeling |
| NDA009866 SOLU-CORTEF | Pharmacia and Upjohn | April 27, 1955 | 41, latest July 10, 2024 2024: Labeling · 2024: Labeling · 2023: Labeling |
| NDA016199 CORTENEMA | Ani Pharms | January 12, 1966 | 14, latest June 3, 2014 2014: Manufacturing (CMC) · 2008: Labeling · 1996: Manufacturing (CMC) |
| NDA213876 ALKINDI SPRINKLE | Eton | September 29, 2020 | 3, latest June 5, 2024 2024: Labeling · 2022: Labeling · 2022: Labeling |
| NDA218980 KHINDIVI | Eton | May 28, 2025 | — |
Generic approvals (27)
- ANDA083231Legacy · February 28, 1973
- ANDA080706Crown Labs · March 9, 1973
- ANDA080692Fougera Pharms · April 16, 1975
- ANDA080693Fougera Pharms Inc · April 30, 1976
- ANDA085070Chartwell Molecular · May 7, 1976
- ANDA085027Padagis Us · November 30, 1977
- ANDA085025Padagis Us · April 21, 1983
- ANDA087795Actavis Mid Atlantic · May 3, 1983
- ANDA088250Salix Pharms · June 6, 1984
- ANDA088799Taro · November 9, 1984
- ANDA089074Padagis Us · November 26, 1985
- ANDA089414Fougera Pharms Inc · December 16, 1986
- ANDA089682Actavis Mid Atlantic · March 10, 1988
- ANDA081271Mission Pharma · April 17, 1992
- ANDA081203Fougera Pharms Inc · May 28, 1993
- ANDA075172Chartwell · December 3, 1999
- ANDA040646Impax Labs Inc · March 30, 2007
- ANDA040879Rising · August 20, 2010
- ANDA207029Strides Pharma · April 27, 2017
- ANDA203810Encube · July 23, 2018
- ANDA214649Aurobindo Pharma Ltd · July 17, 2023
- ANDA214050Cipla · September 5, 2024
- ANDA217160Adaptis · November 25, 2024
- ANDA217881Novitium Pharma · May 2, 2025
- ANDA219856Apotex · February 5, 2026
- ANDA220329Appco · February 25, 2026
- ANDA217191Zydus Pharms · May 7, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
October 1, 2026 · Class II · Ongoing · D-0039-2027
Failed Impurities/Degradation Specifications.
Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara - 391510 India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, — Zydus Pharmaceuticals (USA) Inc
-
April 13, 2022 · Class II · Terminated · D-1045-2022
cGMP deviations: Temperature abuse
Hydrocortisone Ointment USP, 2.5%, NET WT 28.35 g (1 oz) tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0146-30 — Mckesson Medical-Surgical Inc. Corporate Office
-
May 7, 2018 · Class II · Terminated · D-0817-2018
Failed Stability Specifications
Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed by Perrigo, Allegan MI 49010, NDC 45802-014-02 — Perrigo New York
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 102250, 103401, 105398, 106258, 197782, 197783, 197784, 197785, 197786, 197787 … (+10) |
|---|---|
| SPL set ID of the quoted label | 9ce19944-dd88-4a7b-84ca-b07f4ec23bad |
| FDA labels (SPL) | 99 |
| FDA applications | NDA008697, NDA009866, NDA016199, NDA213876, NDA218980, 27 ANDA |
| Active ingredients (FDA) | HYDROCORTISONE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cortef, Pharmacia & Upjohn Company LLC, effective February 17, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →