FDA Orange Book
Generic for Aggrastat
Aggrastat contains tirofiban. 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 Aggrastat is tirofiban. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 5 Aggrastat products the Orange Book lists.
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Aggrastat products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) | Discontinued | None | 0 | None |
| solution, injection | EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) | Marketed (Rx) | AP | 3 | AP |
| solution, intravenous | EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) | Discontinued | None | 0 | None |
| solution, intravenous | EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) | Marketed (Rx) | AP | 2 | AP |
NDA 020912, 020913, held by MEDICURE INTERNATIONAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tirofiban
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| GLAND PHARMA LTD | 206888 | AP (A-rated, therapeutically equivalent) | April 8, 2021 | EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) |
| EUGIA PHARMA SPECIALITIES LTD | 216379 | AP (A-rated, therapeutically equivalent) | May 1, 2023 | EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML), EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) |
| NEXUS PHARMACEUTICALS LLC | 213947 | AP (A-rated, therapeutically equivalent) | July 24, 2023 | EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML), EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) |
Aggrastat NDC codes
Questions
Is there a generic for Aggrastat?
Yes. The generic name for Aggrastat is tirofiban. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 5 Aggrastat products the Orange Book lists.
What is the generic name for Aggrastat?
The active ingredient in Aggrastat is tirofiban, 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.