FDA Orange Book

Generic for Halog

Halog contains halcinonide. 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 Halog is halcinonide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AT. Generics match 2 of the 5 Halog products the Orange Book lists.

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Halog products in the Orange Book

Halog products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
cream, topical0.025%DiscontinuedNone0None
cream, topical0.1%Marketed (Rx)AB2AB
ointment, topical0.025%DiscontinuedNone0None
ointment, topical0.1%DiscontinuedNone0None
solution, topical0.1%Marketed (Rx)AT1AT

NDA 017818, 017556, 018125, 017824, 017823, 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 halcinonide

Approved generic versions of Halog
CompanyANDATE codeApprovedStrengths
MYLAN PHARMACEUTICALS INC211027AB (A-rated, therapeutically equivalent)August 12, 20190.1%
CHARTWELL RX SCIENCES LLC214723AB (A-rated, therapeutically equivalent)September 8, 20210.1%
ENCUBE ETHICALS PRIVATE LTD217671AT (A-rated, therapeutically equivalent)May 29, 20240.1%

Halog NDC codes

Questions

Is there a generic for Halog?

Yes. The generic name for Halog is halcinonide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AT. Generics match 2 of the 5 Halog products the Orange Book lists.

What is the generic name for Halog?

The active ingredient in Halog is halcinonide, 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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