Drug
Who makes hydrocortisone?
38 companies list hydrocortisone as a human prescription drug, including under the names Alkindi Sprinkle, CORTEF, Cortenema, Khindivi, Ala-Scalp, Alacort, Anusol HC, Hydroxym. Forms: cream; enema; gel; granule; lotion; ointment; solution; suspension; tablet. Routes: oral, rectal, topical.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing hydrocortisone
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | cream; lotion; ointment; tablet | ANDAANDA040646, ANDA080706, ANDA081203 | 23 | 1 |
| ANI Pharmaceuticals, Inc.United States | cream; enema; tablet | ANDA, NDA, NDA AUTHORIZED GENERICANDA080706, ANDA217881, NDA016199 | 7 | 1 |
| Strides Pharma Science LimitedIndia | tablet | ANDAANDA207029 | 6 | 5 |
| International Medication Systems, Ltd.United States | cream; ointment | ANDAANDA080706, ANDA085025, ANDA085027 | 5 | 3 |
| Eton Pharmaceuticals, Inc. | granule; solution | NDANDA213876, NDA218980 | 5 | 0 |
| Crown LaboratoriesUnited States | cream | ANDAANDA080706 | 4 | 1 |
| NuCare Pharmaceuticals,Inc.United States | cream | ANDAANDA085025, ANDA088799, ANDA089682 | 4 | 1 |
| Preferred Pharmaceuticals Inc.United States | cream; tablet | ANDAANDA040646, ANDA080706, ANDA085025 | 4 | 1 |
| Chartwell RX, LLC. | suspension; tablet | ANDAANDA075172, ANDA085070, ANDA207029 | 4 | 0 |
| E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | cream; ointment | ANDAANDA080692, ANDA080693, ANDA081203 | 4 | 0 |
| Amneal Pharmaceuticals of New York, LLCIndia | tablet | ANDAANDA040646 | 3 | 14 |
| Aurobindo Pharma LimitedIndia | tablet | ANDAANDA214649 | 3 | 6 |
| Padagis Israel Pharmaceuticals LtdUnited States | cream; lotion; ointment | ANDAANDA085025, ANDA085027, ANDA089074 | 3 | 2 |
| PD-Rx Pharmaceuticals Inc.United States | tablet | ANDAANDA207029 | 3 | 1 |
| Proficient Rx LPUnited States | cream; ointment | ANDAANDA085025, ANDA085027, ANDA089682 | 3 | 1 |
| AvPAK | tablet | ANDAANDA040646 | 3 | 0 |
| Eywa Pharma Inc | tablet | ANDAANDA217160 | 3 | 0 |
| Mylan Pharmaceuticals, Inc. | tablet | NDA AUTHORIZED GENERICNDA008697 | 3 | 0 |
| Pharmacia and Upjohn Company LLC | tablet | NDANDA008697 | 3 | 0 |
| Solco healthcare U.S., LLC | tablet | ANDAANDA220329 | 3 | 0 |
| Sun Pharmaceutical Industries LimitedIndia | cream | ANDAANDA088799 | 2 | 13 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA207029 | 2 | 5 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | tablet | ANDA, NDA AUTHORIZED GENERICANDA207029, NDA008697 | 2 | 1 |
| Direct RxUnited States | cream | ANDAANDA087795, ANDA088799 | 2 | 1 |
| Sportpharm LLC | cream | ANDAANDA080706, ANDA089414 | 2 | 0 |
| Encube Ethicals LimitedIndia | cream | ANDAANDA203810 | 1 | 5 |
| PureTek CorporationUnited States | gel | UNAPPROVED DRUG OTHER | 1 | 2 |
| Actavis LLCUnited States | cream | ANDAANDA087795 | 1 | 1 |
| Derm Ventures, LLCUnited States | lotion | ANDAANDA083231 | 1 | 1 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.United States | suspension | ANDAANDA075172 | 1 | 1 |
| Leading Pharma, LLCUnited States | cream | ANDAANDA085025 | 1 | 1 |
| Mission Pharmacal CompanyUnited States | solution | ANDAANDA081271 | 1 | 1 |
| Oncora Pharma, LLCUnited States | gel | UNAPPROVED DRUG OTHER | 1 | 1 |
| RemedyRepack, IncUnited States | cream | ANDAANDA085025 | 1 | 1 |
| Trifluent Pharma LLCUnited States | solution | ANDAANDA081271 | 1 | 1 |
| MAJOR Pharmaceuticals Inc. | tablet | ANDAANDA040646 | 1 | 0 |
| Redmont Pharmaceuticals, LLC | gel | UNAPPROVED DRUG OTHER | 1 | 0 |
| Salix Pharmaceuticals, Inc. | cream | ANDAANDA088250 | 1 | 0 |
Bulk ingredient listings
- Henan Lihua Pharmaceutical Co LtdChina · 4 NDC
- Shandong Xinhua Pharmaceutical Company LimitedChina · 4 NDC
- Pharmacia and Upjohn Company LLC · 2 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 2 NDC
- ASCLEMED USA INC. DBA ENOVACHEMUnited States · 1 NDC
- EUROAPIFrance · 1 NDC
- Farmabios S.p.A.Italy · 1 NDC
- Galenova IncCanada · 1 NDC
- Jiangsu Lianhuan Pharmaceutical Co.,Ltd. · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- McKinley Resources Inc.United States · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Suresource Pharma LLCUnited States · 1 NDC
- Symbiotec Pharmalab LimitedIndia · 1 NDC
- Tianjin Tianyao Pharmaceuticals Co., Ltd.China · 1 NDC
- XENEX LABORATORIES INCCanada · 1 NDC
- Zhejiang Xianju Pharmaceutical Co., Ltd.China · 1 NDC
Orange Book patents
5 unexpired patents list hydrocortisone as the active ingredient, expiring between Nov 2032 and Feb 2043. Application holder: ETON PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes hydrocortisone?
- 38 companies list hydrocortisone as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, ANI Pharmaceuticals, Inc., Strides Pharma Science Limited, International Medication Systems, Ltd., Eton Pharmaceuticals, Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Alkindi Sprinkle?
- 32 companies list hydrocortisone under an abbreviated new drug application (ANDA), the application type used for generics, and 3 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies hydrocortisone active ingredient?
- 17 companies list hydrocortisone as a bulk ingredient, including Henan Lihua Pharmaceutical Co Ltd, Shandong Xinhua Pharmaceutical Company Limited, Pharmacia and Upjohn Company LLC, Professional Compounding Centers of America dba PCCA.