FDA Orange Book

Generic for Primaxin

Primaxin contains imipenem and cilastatin. 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 Primaxin is imipenem and cilastatin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 4 Primaxin products the Orange Book lists.

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Primaxin products in the Orange Book

Primaxin products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
powder, intramuscularEQ 500MG BASE/VIAL;500MG/VIALDiscontinuedNone0None
powder, intramuscularEQ 750MG BASE/VIAL;750MG/VIALDiscontinuedNone0None
powder, intravenousEQ 250MG BASE/VIAL;250MG/VIALDiscontinuedNone1None
powder, intravenousEQ 500MG BASE/VIAL;500MG/VIALMarketed (Rx)AP2AP

NDA 050630, 050587, held by MERCK AND CO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic imipenem and cilastatin

Approved generic versions of Primaxin
CompanyANDATE codeApprovedStrengths
ACS DOBFAR SPA090577None (No TE code listed)December 21, 2011EQ 250MG BASE/VIAL;250MG/VIAL, EQ 500MG BASE/VIAL;500MG/VIAL
HQ SPECIALTY PHARMA CORP207594AP (A-rated, therapeutically equivalent)December 12, 2019EQ 500MG BASE/VIAL;500MG/VIAL

Primaxin NDC codes

Questions

Is there a generic for Primaxin?

Yes. The generic name for Primaxin is imipenem and cilastatin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 4 Primaxin products the Orange Book lists.

What is the generic name for Primaxin?

The active ingredient in Primaxin is imipenem and cilastatin, 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.

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