FDA Orange Book
Generic for Zinacef
Zinacef contains cefuroxime. 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 Zinacef is cefuroxime. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 2 of the 3 Zinacef products the Orange Book lists.
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Zinacef products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 1.5GM BASE/VIAL | Discontinued | None | 2 | AP |
| injectable, injection | EQ 7.5GM BASE/VIAL | Discontinued | None | 0 | None |
| injectable, intramuscular, intravenous | EQ 750MG BASE/VIAL | Discontinued | None | 2 | AB |
NDA 050558, held by PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic cefuroxime
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACS DOBFAR SPA | 064125 | AP (A-rated, therapeutically equivalent) | May 30, 1997 | EQ 1.5GM BASE/VIAL, EQ 750MG BASE/VIAL |
| HIKMA FARMACEUTICA PORTUGAL SA | 065048 | AP (A-rated, therapeutically equivalent) | January 9, 2004 | EQ 1.5GM BASE/VIAL, EQ 750MG BASE/VIAL |
Questions
Is there a generic for Zinacef?
Yes. The generic name for Zinacef is cefuroxime. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 2 of the 3 Zinacef products the Orange Book lists.
What is the generic name for Zinacef?
The active ingredient in Zinacef is cefuroxime, 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.