FDA Orange Book
Generic for Hemabate
Hemabate contains carboprost. 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 Hemabate is carboprost. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Hemabate products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 0.25MG BASE/ML | Marketed (Rx) | AP | 12 | AP |
NDA 017989, 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 carboprost
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES LTD | 211941 | AP (A-rated, therapeutically equivalent) | July 2, 2019 | EQ 0.25MG BASE/ML |
| SUNNY PHARMTECH INC | 213118 | AP (A-rated, therapeutically equivalent) | March 25, 2021 | EQ 0.25MG BASE/ML |
| AMNEAL EU LTD | 215337 | AP (A-rated, therapeutically equivalent) | January 27, 2022 | EQ 0.25MG BASE/ML |
| LONG GROVE PHARMACEUTICALS LLC | 214499 | AP (A-rated, therapeutically equivalent) | August 9, 2022 | EQ 0.25MG BASE/ML |
| CAPLIN STERILES LTD | 216882 | AP (A-rated, therapeutically equivalent) | February 13, 2023 | EQ 0.25MG BASE/ML |
| SOLA PHARMACEUTICALS | 216824 | AP (A-rated, therapeutically equivalent) | May 19, 2023 | EQ 0.25MG BASE/ML |
| EUGIA PHARMA SPECIALITIES LTD | 216939 | AP (A-rated, therapeutically equivalent) | May 25, 2023 | EQ 0.25MG BASE/ML |
| ALEMBIC PHARMACEUTICALS LTD | 217198 | AP (A-rated, therapeutically equivalent) | June 15, 2023 | EQ 0.25MG BASE/ML |
| ONESOURCE SPECIALTY PTE LTD | 216897 | AP (A-rated, therapeutically equivalent) | July 25, 2023 | EQ 0.25MG BASE/ML |
| GLAND PHARMA LTD | 217657 | AP (A-rated, therapeutically equivalent) | August 7, 2023 | EQ 0.25MG BASE/ML |
| MICRO LABS LTD | 218013 | AP (A-rated, therapeutically equivalent) | April 3, 2024 | EQ 0.25MG BASE/ML |
| SOMERSET THERAPEUTICS LLC | 219529 | AP (A-rated, therapeutically equivalent) | May 27, 2026 | EQ 0.25MG BASE/ML |
Hemabate NDC codes
Questions
Is there a generic for Hemabate?
Yes. The generic name for Hemabate is carboprost. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Hemabate?
The active ingredient in Hemabate is carboprost, 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.