FDA Orange Book

Generic for Daytrana

Daytrana contains methylphenidate. 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 Daytrana is methylphenidate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Daytrana products in the Orange Book

Daytrana products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
film, extended release, transdermal	10MG/9HR (1.1MG/HR)	Marketed (Rx)	AB	1	AB
film, extended release, transdermal	15MG/9HR (1.6MG/HR)	Marketed (Rx)	AB	1	AB
film, extended release, transdermal	20MG/9HR (2.2MG/HR)	Marketed (Rx)	AB	1	AB
film, extended release, transdermal	30MG/9HR (3.3MG/HR)	Marketed (Rx)	AB	1	AB

NDA 021514, held by NOVEN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic methylphenidate

Approved generic versions of Daytrana
Company	ANDA	TE code	Approved	Strengths
MYLAN TECHNOLOGIES INC A VIATRIS CO	206497	AB (A-rated, therapeutically equivalent)	March 14, 2022	10MG/9HR (1.1MG/HR), 15MG/9HR (1.6MG/HR), 20MG/9HR (2.2MG/HR), 30MG/9HR (3.3MG/HR)

Daytrana NDC codes

Questions

Is there a generic for Daytrana?

Yes. The generic name for Daytrana is methylphenidate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Daytrana?

The active ingredient in Daytrana is methylphenidate, 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.