FDA Orange Book

Generic for Mefoxin

Mefoxin contains cefoxitin. 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 Mefoxin is cefoxitin. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

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Mefoxin products in the Orange Book

Mefoxin products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
injectable, injectionEQ 10GM BASE/VIALDiscontinuedNone3AP
injectable, injectionEQ 1GM BASE/VIALDiscontinuedNone3AP
injectable, injectionEQ 2GM BASE/VIALDiscontinuedNone3AP

NDA 050517, held by PHARMOBEDIENT CONSULTING LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic cefoxitin

Approved generic versions of Mefoxin
CompanyANDATE codeApprovedStrengths
HIKMA PHARMACEUTICALS USA INC065050AP (A-rated, therapeutically equivalent)September 11, 2000EQ 10GM BASE/VIAL
HIKMA PHARMACEUTICALS USA INC065051AP (A-rated, therapeutically equivalent)September 11, 2000EQ 1GM BASE/VIAL, EQ 2GM BASE/VIAL
ACS DOBFAR SPA065414AP (A-rated, therapeutically equivalent)June 12, 2009EQ 1GM BASE/VIAL, EQ 2GM BASE/VIAL
HIKMA FARMACEUTICA (PORTUGAL) SA065239AP (A-rated, therapeutically equivalent)March 2, 2010EQ 10GM BASE/VIAL
HIKMA FARMACEUTICA (PORTUGAL) SA065238AP (A-rated, therapeutically equivalent)March 12, 2010EQ 1GM BASE/VIAL, EQ 2GM BASE/VIAL
ACS DOBFAR SPA065415AP (A-rated, therapeutically equivalent)May 19, 2010EQ 10GM BASE/VIAL

Questions

Is there a generic for Mefoxin?

Yes. The generic name for Mefoxin is cefoxitin. 3 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 Mefoxin?

The active ingredient in Mefoxin is cefoxitin, 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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