FDA Orange Book
Generic for Maxipime
Maxipime contains cefepime. 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 Maxipime is cefepime. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Maxipime products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 1GM BASE/VIAL | Discontinued | None | 4 | AP |
| injectable, injection | EQ 2GM BASE/VIAL | Discontinued | None | 4 | AP |
| injectable, injection | EQ 500MG BASE/VIAL | Discontinued | None | 1 | None |
NDA 050679, held by HOSPIRA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic cefepime
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACS DOBFAR SPA | 065441 | AP (A-rated, therapeutically equivalent) | March 20, 2008 | EQ 1GM BASE/VIAL, EQ 2GM BASE/VIAL |
| QILU ANTIBIOTICS PHARMACEUTICAL CO LTD | 203704 | AP (A-rated, therapeutically equivalent) | February 1, 2016 | EQ 1GM BASE/VIAL, EQ 2GM BASE/VIAL, EQ 500MG BASE/VIAL |
| SAGENT PHARMACEUTICALS INC | 091048 | AP (A-rated, therapeutically equivalent) | January 4, 2017 | EQ 1GM BASE/VIAL, EQ 2GM BASE/VIAL |
| HIKMA PHARMACEUTICALS USA INC | 214402 | AP (A-rated, therapeutically equivalent) | May 22, 2024 | EQ 1GM BASE/VIAL, EQ 2GM BASE/VIAL |
Questions
Is there a generic for Maxipime?
Yes. The generic name for Maxipime is cefepime. 4 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 Maxipime?
The active ingredient in Maxipime is cefepime, 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.