FDA Orange Book

Generic for Focalin

Focalin contains dexmethylphenidate. 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 Focalin is dexmethylphenidate. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Focalin products in the Orange Book

Focalin products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	10MG	Marketed (Rx)	AB	6	AB
tablet, oral	2.5MG	Marketed (Rx)	AB	5	AB
tablet, oral	5MG	Marketed (Rx)	AB	6	AB

NDA 021278, held by SANDOZ INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic dexmethylphenidate

Approved generic versions of Focalin
Company	ANDA	TE code	Approved	Strengths
SUN PHARMACEUTICAL INDUSTRIES INC	201231	AB (A-rated, therapeutically equivalent)	September 24, 2015	10MG, 2.5MG, 5MG
ABHAI LLC	206931	AB (A-rated, therapeutically equivalent)	December 4, 2015	10MG, 2.5MG, 5MG
NOVEL LABORATORIES INC	204534	AB (A-rated, therapeutically equivalent)	December 4, 2015	10MG, 2.5MG, 5MG
TRIS PHARMA INC	207901	AB (A-rated, therapeutically equivalent)	August 26, 2016	10MG, 2.5MG, 5MG
CEDIPROF INC	209211	AB (A-rated, therapeutically equivalent)	September 19, 2018	10MG, 5MG
ALKEM LABORATORIES LTD	212631	AB (A-rated, therapeutically equivalent)	July 19, 2019	10MG, 2.5MG, 5MG

Focalin NDC codes

Questions

Is there a generic for Focalin?

Yes. The generic name for Focalin is dexmethylphenidate. 6 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 Focalin?

The active ingredient in Focalin is dexmethylphenidate, 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.