FDA Orange Book
Generic for Merrem IV
Merrem IV contains meropenem. 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 Merrem IV is meropenem. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Merrem IV products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 1GM/VIAL | Discontinued | None | 9 | AP |
| injectable, injection | 500MG/VIAL | Discontinued | None | 9 | AP |
NDA 050706, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic meropenem
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACS DOBFAR SPA | 091404 | AP (A-rated, therapeutically equivalent) | October 26, 2011 | 1GM/VIAL, 500MG/VIAL |
| AMNEAL PHARMACEUTICALS | 205883 | AP (A-rated, therapeutically equivalent) | April 12, 2016 | 1GM/VIAL, 500MG/VIAL |
| SAVIOR LIFETEC CORP | 206086 | AP (A-rated, therapeutically equivalent) | April 19, 2016 | 1GM/VIAL, 500MG/VIAL |
| GLAND PHARMA LTD | 206141 | AP (A-rated, therapeutically equivalent) | June 8, 2016 | 1GM/VIAL, 500MG/VIAL |
| ACS DOBFAR SPA | 204139 | AP (A-rated, therapeutically equivalent) | June 9, 2016 | 1GM/VIAL, 500MG/VIAL |
| EUGIA PHARMA SPECIALITIES LTD | 205835 | AP (A-rated, therapeutically equivalent) | March 27, 2017 | 1GM/VIAL, 500MG/VIAL |
| HQ SPECIALTY PHARMA CORP | 210773 | AP (A-rated, therapeutically equivalent) | August 16, 2019 | 1GM/VIAL, 500MG/VIAL |
| BROOKS STERISCIENCE LTD | 216154 | AP (A-rated, therapeutically equivalent) | August 18, 2022 | 1GM/VIAL, 500MG/VIAL |
| QILU PHARMACEUTICAL CO LTD | 216424 | AP (A-rated, therapeutically equivalent) | July 22, 2024 | 1GM/VIAL, 500MG/VIAL |
Questions
Is there a generic for Merrem IV?
Yes. The generic name for Merrem IV is meropenem. 8 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 Merrem IV?
The active ingredient in Merrem IV is meropenem, 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.