FDA Orange Book

Generic for Carbatrol

Carbatrol contains carbamazepine. 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 Carbatrol is carbamazepine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Carbatrol products in the Orange Book

Carbatrol products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
capsule, extended release, oral	100MG	Marketed (Rx)	AB	3	AB
capsule, extended release, oral	200MG	Marketed (Rx)	AB	3	AB
capsule, extended release, oral	300MG	Marketed (Rx)	AB	3	AB

NDA 020712, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic carbamazepine

Approved generic versions of Carbatrol
Company	ANDA	TE code	Approved	Strengths
ANI PHARMACEUTICALS INC	076697	AB (A-rated, therapeutically equivalent)	May 20, 2011	100MG, 200MG, 300MG
APOTEX INC	078986	AB (A-rated, therapeutically equivalent)	November 25, 2011	100MG, 200MG, 300MG
TEVA PHARMACEUTICALS USA	078592	AB (A-rated, therapeutically equivalent)	September 20, 2012	100MG, 200MG, 300MG

Carbatrol NDC codes

Questions

Is there a generic for Carbatrol?

Yes. The generic name for Carbatrol is carbamazepine. 3 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 Carbatrol?

The active ingredient in Carbatrol is carbamazepine, 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.