FDA Orange Book

Generic for Duricef

Duricef contains cefadroxil/cefadroxil. 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 Duricef is cefadroxil/cefadroxil. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 6 Duricef products the Orange Book lists.

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Duricef products in the Orange Book

Duricef products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, oralEQ 250MG BASEDiscontinuedNone0None
capsule, oralEQ 500MG BASEDiscontinuedNone3AB
for suspension, oralEQ 125MG BASE/5MLDiscontinuedNone0None
for suspension, oralEQ 250MG BASE/5MLDiscontinuedNone2AB
for suspension, oralEQ 500MG BASE/5MLDiscontinuedNone2AB
tablet, oralEQ 1GM BASEDiscontinuedNone1None

NDA 050512, 050527, 050528, held by WARNER CHILCOTT INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic cefadroxil/cefadroxil

Approved generic versions of Duricef
CompanyANDATE codeApprovedStrengths
TEVA PHARMACEUTICALS USA062774None (No TE code listed)April 8, 1987EQ 1GM BASE
TEVA PHARMACEUTICALS USA065282AB (A-rated, therapeutically equivalent)January 20, 2006EQ 500MG BASE
AUROBINDO PHARMA LTD065352AB (A-rated, therapeutically equivalent)January 25, 2007EQ 500MG BASE
LUPIN LTD065392AB (A-rated, therapeutically equivalent)May 29, 2007EQ 500MG BASE
LUPIN LTD065396AB (A-rated, therapeutically equivalent)February 21, 2008EQ 250MG BASE/5ML, EQ 500MG BASE/5ML
AUROBINDO PHARMA LTD065349AB (A-rated, therapeutically equivalent)April 25, 2013EQ 250MG BASE/5ML, EQ 500MG BASE/5ML

Questions

Is there a generic for Duricef?

Yes. The generic name for Duricef is cefadroxil/cefadroxil. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 6 Duricef products the Orange Book lists.

What is the generic name for Duricef?

The active ingredient in Duricef is cefadroxil/cefadroxil, 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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