Active ingredient
Medroxyprogesterone
48 finished FDA listings contain Medroxyprogesterone as their only active ingredient; 4 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- MEDROXYPROGESTERONE ACETATE
- Dosage forms
- Injection, Suspension, Injection, Suspension, Extended Release, Tablet
- Routes
- Intramuscular, Oral, Subcutaneous
- Manufacturers / labelers
- 24
- Strengths listed
- 10 mg/1 · 104 mg/.65ml · 150 mg/ml · 2.5 mg/1 · 5 mg/1
- Brand names in FDA listings
- Depo-Provera, Depo-Subq Provera, Medroxyprogesterone Acetate Injectable Suspension, Provera
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 6691
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 011839 | PFIZER | 1959-06-18 | 6 |
| NDA 020246 | PFIZER | 1992-10-29 | 6 |
| ANDA 040159 | BARR | 1996-08-09 | 22 |
| NDA 021583 | PFIZER | 2004-12-17 | 1 |
| ANDA 077235 | AMPHASTAR PHARMS INC | 2017-11-28 | 1 |
| ANDA 077334 | AMPHASTAR PHARMS INC | 2017-11-28 | 1 |
| ANDA 210227 | XIROMED | 2018-10-12 | 3 |
| ANDA 210761 | SUN PHARM | 2019-04-24 | 1 |
| ANDA 210760 | SUN PHARM | 2019-05-01 | 1 |
| ANDA 212824 | EUGIA PHARMA | 2022-08-22 | 1 |
| ANDA 212844 | EUGIA PHARMA | 2022-08-31 | 1 |
| ANDA 214309 | HIKMA | 2023-01-05 | 1 |
| ANDA 215397 | AMNEAL | 2023-06-07 | 3 |
Official labeling on DailyMed
- MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [REMEDYREPACK INC.] · version 3 · 2026-09-07
- MEDROXYPROGESTERONE ACETATE TABLET [REMEDYREPACK INC.] · version 2 · 2026-09-02
- MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [PRASCO LABORATORIES] · version 12 · 2026-08-31
- DEPO-PROVERA (MEDROXYPROGESTERONE ACETATE) INJECTION, SUSPENSION [PHARMACIA & UPJOHN COMPANY LLC] · version 29 · 2026-08-28
- MEDROXYPROGESTERONE ACETATE TABLET [REMEDYREPACK INC.] · version 7 · 2026-07-22
- MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [XIROMED LLC] · version 7 · 2026-07-03
- PROVERA (MEDROXYPROGESTERONE ACETATE) TABLET [PHARMACIA & UPJOHN COMPANY LLC] · version 27 · 2026-06-30
- MEDROXYPROGESTERONE ACETATE TABLET [PREFERRED PHARMACEUTICALS, INC.] · version 12 · 2026-06-17
- MEDROXYPROGESTERONE ACETATE TABLET [PREFERRED PHARMACEUTICALS INC.] · version 6 · 2026-06-17
- MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION, EXTENDED RELEASE [AMPHASTAR PHARMACEUTICALS, INC.] · version 9 · 2026-06-03
- MEDROXYPROGESTERONE ACETATE TABLET [MYLAN PHARMACEUTICALS INC.] · version 33 · 2026-05-25
- MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS] · version 6 · 2026-02-25
Showing the 12 most recent of 36 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.