FDA Orange Book
Generic for Amicar
Amicar contains aminocaproic acid. 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 Amicar is aminocaproic acid. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AP.
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Amicar products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 250MG/ML | Discontinued | None | 3 | AP |
| solution, oral | 0.25GM/ML | Marketed (Rx) | AA | 10 | AA |
| tablet, oral | 1GM | Marketed (Rx) | AB | 4 | AB |
| tablet, oral | 500MG | Marketed (Rx) | AB | 5 | AB |
NDA 015229, 015230, 015197, held by EPIC PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic aminocaproic acid
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HOSPIRA INC | 070010 | AP (A-rated, therapeutically equivalent) | March 9, 1987 | 250MG/ML |
| LUITPOLD PHARMACEUTICALS INC | 071192 | AP (A-rated, therapeutically equivalent) | December 1, 1987 | 250MG/ML |
| SUNNY PHARMTECH INC | 209060 | AB (A-rated, therapeutically equivalent) | November 27, 2018 | 1GM, 500MG |
| AMNEAL PHARMACEUTICALS LLC | 212780 | AA (A-rated, therapeutically equivalent) | August 23, 2019 | 0.25GM/ML |
| AMNEAL EU LTD | 212492 | AB (A-rated, therapeutically equivalent) | November 26, 2019 | 500MG |
| TP ANDA HOLDINGS LLC | 212494 | AA (A-rated, therapeutically equivalent) | August 11, 2020 | 0.25GM/ML |
| CARNEGIE PHARMACEUTICALS LLC | 214140 | AA (A-rated, therapeutically equivalent) | January 26, 2021 | 0.25GM/ML |
| PHARMOBEDIENT CONSULTING LLC | 213928 | AB (A-rated, therapeutically equivalent) | February 12, 2021 | 1GM, 500MG |
| AJENAT PHARMACEUTICALS LLC | 213825 | AA (A-rated, therapeutically equivalent) | April 8, 2021 | 0.25GM/ML |
| REGCON HOLDINGS LLC | 215510 | AA (A-rated, therapeutically equivalent) | March 23, 2022 | 0.25GM/ML |
| RISING PHARMA HOLDINGS INC | 213944 | AB (A-rated, therapeutically equivalent) | September 14, 2022 | 1GM, 500MG |
| AUROBINDO PHARMA LTD | 216804 | AA (A-rated, therapeutically equivalent) | September 26, 2022 | 0.25GM/ML |
| ANNORA PHARMA PRIVATE LTD | 216464 | AA (A-rated, therapeutically equivalent) | November 4, 2022 | 0.25GM/ML |
| MSN LABORATORIES PRIVATE LTD | 212938 | AB (A-rated, therapeutically equivalent) | September 13, 2023 | 1GM, 500MG |
| SUNNY PHARMTECH INC | 213213 | AA (A-rated, therapeutically equivalent) | December 27, 2023 | 0.25GM/ML |
| MSN LABORATORIES PRIVATE LTD | 215100 | AA (A-rated, therapeutically equivalent) | September 26, 2024 | 0.25GM/ML |
| PHARMAZONE | 213216 | AA (A-rated, therapeutically equivalent) | May 19, 2025 | 0.25GM/ML |
| ZENARA PHARMA PRIVATE LTD | 215374 | AP (A-rated, therapeutically equivalent) | August 28, 2025 | 250MG/ML |
Amicar NDC codes
Questions
Is there a generic for Amicar?
Yes. The generic name for Amicar is aminocaproic acid. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AP.
What is the generic name for Amicar?
The active ingredient in Amicar is aminocaproic acid, 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.