FDA Orange Book

Generic for Pathocil

Pathocil contains dicloxacillin. 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 Pathocil is dicloxacillin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Pathocil products the Orange Book lists.

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Pathocil products in the Orange Book

Pathocil products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, oralEQ 250MG BASEDiscontinuedNone2AB
capsule, oralEQ 500MG BASEDiscontinuedNone2AB
for suspension, oralEQ 62.5MG BASE/5MLDiscontinuedNone0None

NDA 050011, 050092, held by WYETH AYERST LABORATORIES. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic dicloxacillin

Approved generic versions of Pathocil
CompanyANDATE codeApprovedStrengths
CHARTWELL RX SCIENCES LLC062286AB (A-rated, therapeutically equivalent)June 3, 1982EQ 250MG BASE, EQ 500MG BASE
AUROBINDO PHARMA LTD216845AB (A-rated, therapeutically equivalent)September 23, 2022EQ 250MG BASE, EQ 500MG BASE

Questions

Is there a generic for Pathocil?

Yes. The generic name for Pathocil is dicloxacillin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Pathocil products the Orange Book lists.

What is the generic name for Pathocil?

The active ingredient in Pathocil is dicloxacillin, 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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