FDA Orange Book

Generic for Westcort

Westcort contains hydrocortisone valerate. 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 Westcort is hydrocortisone valerate. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Westcort products in the Orange Book

Westcort products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
cream, topical0.2%DiscontinuedNone4AB
ointment, topical0.2%DiscontinuedNone2AB

NDA 017950, 018726, held by SUN PHARMACEUTICAL INDUSTRIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic hydrocortisone valerate

Approved generic versions of Westcort
CompanyANDATE codeApprovedStrengths
SUN PHARMA CANADA INC075042AB (A-rated, therapeutically equivalent)August 25, 19980.2%
SUN PHARMA CANADA INC075043AB (A-rated, therapeutically equivalent)August 25, 19980.2%
LUPIN LTD210307AB (A-rated, therapeutically equivalent)August 15, 20190.2%
COSETTE PHARMACEUTICALS NC LABORATORIES LLC211764AB (A-rated, therapeutically equivalent)March 4, 20200.2%
COSETTE PHARMACEUTICALS NC LABORATORIES LLC213724AB (A-rated, therapeutically equivalent)February 11, 20210.2%
ENCUBE ETHICALS PVT LTD211047AB (A-rated, therapeutically equivalent)November 4, 20210.2%

Questions

Is there a generic for Westcort?

Yes. The generic name for Westcort is hydrocortisone valerate. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Westcort?

The active ingredient in Westcort is hydrocortisone valerate, 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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