FDA Orange Book

Generic for Locoid

Locoid contains hydrocortisone butyrate. 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 Locoid is hydrocortisone butyrate. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AB1, AB2, AT.

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Locoid products in the Orange Book

Locoid products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
cream, topical0.1%Marketed (Rx)AB12AB1, AB2
cream, topical0.1%DiscontinuedNone2AB1, AB2
lotion, topical0.1%DiscontinuedNone2AB
ointment, topical0.1%DiscontinuedNone1None
ointment, topical0.1%DiscontinuedNone1None
solution, topical0.1%Marketed (Rx)AT1AT
solution, topical0.1%DiscontinuedNone1AT

NDA 018514, 018795, 022076, 018652, 019106, 019116, 019819, held by BAUSCH HEALTH US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic hydrocortisone butyrate

Approved generic versions of Locoid
CompanyANDATE codeApprovedStrengths
TARO PHARMACEUTICAL INDUSTRIES LTD076364AT (A-rated, therapeutically equivalent)January 14, 20040.1%, 0.1%
TARO PHARMACEUTICAL INDUSTRIES LTD076842None (No TE code listed)December 27, 20040.1%, 0.1%
TARO PHARMACEUTICAL INDUSTRIES LTD076654AB1 (A-rated, therapeutically equivalent)August 3, 20050.1%, 0.1%
THE J MOLNER CO OU209556AB (A-rated, therapeutically equivalent)November 21, 20170.1%
ACTAVIS MID ATLANTIC LLC205134AB2 (A-rated, therapeutically equivalent)December 8, 20170.1%, 0.1%
LUPIN LTD210209AB (A-rated, therapeutically equivalent)August 17, 20180.1%

Locoid NDC codes

Questions

Is there a generic for Locoid?

Yes. The generic name for Locoid is hydrocortisone butyrate. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AB1, AB2, AT.

What is the generic name for Locoid?

The active ingredient in Locoid is hydrocortisone butyrate, 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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