FDA Orange Book
Generic for Depo-Provera
Depo-Provera contains medroxyprogesterone acetate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Depo-Provera is medroxyprogesterone acetate. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 3 Depo-Provera products the Orange Book lists.
Run it in Rivvi
Map Depo-Provera and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Depo-Provera products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 100MG/ML | Discontinued | None | 0 | None |
| injectable, injection | 150MG/ML | Marketed (Rx) | AB | 7 | AB |
| injectable, injection | 400MG/ML | Discontinued | None | 0 | None |
NDA 012541, 020246, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic medroxyprogesterone acetate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HONG KONG KING FRIEND INDUSTRIAL CO LTD | 076553 | AB (A-rated, therapeutically equivalent) | July 28, 2004 | 150MG/ML |
| AMPHASTAR PHARMACEUTICALS INC | 077235 | AB (A-rated, therapeutically equivalent) | November 28, 2017 | 150MG/ML |
| AMPHASTAR PHARMACEUTICALS INC | 077334 | AB (A-rated, therapeutically equivalent) | November 28, 2017 | 150MG/ML |
| XIROMED LLC | 210227 | AB (A-rated, therapeutically equivalent) | October 12, 2018 | 150MG/ML |
| EUGIA PHARMA SPECIALITIES LTD | 212824 | AB (A-rated, therapeutically equivalent) | August 22, 2022 | 150MG/ML |
| EUGIA PHARMA SPECIALITIES LTD | 212844 | AB (A-rated, therapeutically equivalent) | August 31, 2022 | 150MG/ML |
| AMNEAL EU LTD | 215397 | AB (A-rated, therapeutically equivalent) | June 7, 2023 | 150MG/ML |
Depo-Provera NDC codes
Questions
Is there a generic for Depo-Provera?
Yes. The generic name for Depo-Provera is medroxyprogesterone acetate. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 3 Depo-Provera products the Orange Book lists.
What is the generic name for Depo-Provera?
The active ingredient in Depo-Provera is medroxyprogesterone acetate, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
More on Depo-Provera and Medroxyprogesterone Acetate
- What is Medroxyprogesterone Acetate used for?FDA label uses
- Is Medroxyprogesterone Acetate a controlled substance?Federal schedule
- Generic for Depo-SubQ ProveraFDA Orange Book
- Generic for ProveraFDA Orange Book
- Progestins listFDA drug class
- NDC 0009-0746Depo-Provera NDC record
- NDC 0009-7376Depo-Provera NDC record