FDA Orange Book
Generic for Ancef
Ancef contains cefazolin. 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 Ancef is cefazolin. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 3 of the 5 Ancef products the Orange Book lists.
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Ancef products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 10GM BASE/VIAL | Discontinued | None | 4 | AP |
| injectable, injection | EQ 1GM BASE/VIAL | Discontinued | None | 4 | AP |
| injectable, injection | EQ 250MG BASE/VIAL | Discontinued | None | 0 | None |
| injectable, injection | EQ 500MG BASE/VIAL | Discontinued | None | 3 | AP |
| injectable, injection | EQ 5GM BASE/VIAL | Discontinued | None | 0 | None |
NDA 050461, held by GLAXOSMITHKLINE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic cefazolin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 062831 | AP (A-rated, therapeutically equivalent) | September 25, 1992 | EQ 10GM BASE/VIAL, EQ 1GM BASE/VIAL, EQ 500MG BASE/VIAL |
| HIKMA FARMACEUTICA PORTUGAL LDA | 065047 | AP (A-rated, therapeutically equivalent) | September 18, 2001 | EQ 1GM BASE/VIAL, EQ 500MG BASE/VIAL |
| HIKMA FARMACEUTICA PORTUGAL LDA | 065143 | AP (A-rated, therapeutically equivalent) | October 18, 2004 | EQ 10GM BASE/VIAL |
| ACS DOBFAR SPA | 065306 | AP (A-rated, therapeutically equivalent) | October 22, 2008 | EQ 10GM BASE/VIAL |
| ACS DOBFAR SPA | 065303 | AP (A-rated, therapeutically equivalent) | October 22, 2008 | EQ 1GM BASE/VIAL, EQ 500MG BASE/VIAL |
| QILU ANTIBIOTICS PHARMACEUTICAL CO LTD | 203661 | AP (A-rated, therapeutically equivalent) | December 28, 2015 | EQ 1GM BASE/VIAL |
| QILU ANTIBIOTICS PHARMACEUTICAL CO LTD | 209217 | AP (A-rated, therapeutically equivalent) | October 17, 2018 | EQ 10GM BASE/VIAL |
Questions
Is there a generic for Ancef?
Yes. The generic name for Ancef is cefazolin. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 3 of the 5 Ancef products the Orange Book lists.
What is the generic name for Ancef?
The active ingredient in Ancef is cefazolin, 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.