Active ingredient
Methylprednisolone
137 finished FDA listings contain Methylprednisolone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- METHYLPREDNISOLONE, METHYLPREDNISOLONE ACEPONATE, METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE SODIUM SUCCINATE
- Dosage forms
- Injection, Injection, Powder, For Solution, Injection, Powder, Lyophilized, For Solution, Injection, Suspension, Tablet
- Routes
- Intra-Articular, Intralesional, Intramuscular, Intrasynovial, Intravascular, Intravenous, Oral, Soft Tissue
- Manufacturers / labelers
- 42
- Strengths listed
- 1 g/1 · 1 g/16ml · 1 g/8ml · 1 g/ml · 125 mg/1 · 125 mg/2ml · 16 mg/1 · 2 g/1 · 2 g/30.6ml · 2 mg/1 · 20 mg/ml · 32 mg/1 · 4 mg/1 · 40 mg/1 · 40 mg/ml · 500 mg/1 · 500 mg/4ml · 500 mg/8ml · 500 mg/ml · 8 mg/1 · 80 mg/ml
- Brand names in FDA listings
- Depo-Medrol, Medrol, Medroloan Ii Suik, Medroloan Suik, Methylprednisolone Sodium Succinate, Solu-Medrol
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 6902
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 011153 | PFIZER | 1957-10-24 | 10 |
| NDA 011856 | PHARMACIA AND UPJOHN | 1959-05-18 | 27 |
| NDA 011757 | PFIZER | 1959-05-27 | 11 |
| ANDA 040189 | JUBILANT CADISTA | 1997-10-31 | 4 |
| ANDA 040183 | PH HEALTH | 1998-12-22 | 6 |
| ANDA 040583 | FRESENIUS KABI USA | 2004-07-30 | 2 |
| ANDA 040612 | FRESENIUS KABI USA | 2004-08-12 | 1 |
| ANDA 207667 | EUGIA PHARMA | 2015-12-15 | 4 |
| ANDA 202691 | HIKMA | 2016-02-16 | 3 |
| ANDA 207549 | AMNEAL | 2016-11-09 | 2 |
| ANDA 206751 | ZYDUS PHARMS | 2018-04-23 | 13 |
| ANDA 204072 | TIANJIN TIANYAO | 2018-05-14 | 14 |
| ANDA 201835 | SAGENT PHARMS INC | 2018-06-27 | 3 |
| ANDA 209097 | CHARTWELL RX | 2019-02-22 | 5 |
| ANDA 210043 | AMNEAL | 2019-05-20 | 8 |
| ANDA 212396 | TIANJIN KINGYORK | 2021-04-20 | 11 |
| ANDA 203125 | HIKMA | 2022-09-26 | 5 |
| ANDA 211930 | EUGIA PHARMA | 2023-04-13 | 2 |
| ANDA 216502 | AMNEAL | 2023-11-03 | 2 |
| ANDA 220556 | CAPLIN | 2026-01-26 | 2 |
Official labeling on DailyMed
- METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, FOR SOLUTION [REMEDYREPACK INC.] · version 3 · 2026-09-10
- METHYLPREDNISOLONE TABLET [REMEDYREPACK INC.] · version 5 · 2026-09-02
- METHYLPREDNISOLONE TABLET [PD-RX PHARMACEUTICALS, INC.] · version 25 · 2026-08-11
- SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH 107, LLC] · version 15 · 2026-07-28
- METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 2 · 2026-07-27
- SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [SPORTPHARM LLC] · version 1 · 2026-07-24
- METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [SAGENT PHARMACEUTICALS] · version 10 · 2026-07-15
- METHYLPREDNISOLONE TABLET [HAWAII REPACK, INC.] · version 1 · 2026-07-08
- METHYLPREDNISOLONE TABLET [AMERICAN HEALTH PACKAGING] · version 11 · 2026-07-07
- METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 3 · 2026-07-06
- METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 8 · 2026-07-06
- SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [PHARMACIA & UPJOHN COMPANY LLC] · version 12 · 2026-06-26
Showing the 12 most recent of 87 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.