FDA Orange Book

Generic for Nuedexta

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

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Nuedexta products in the Orange Book

Nuedexta products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
capsule, oral	20MG;10MG	Marketed (Rx)	AB	3	AB

NDA 021879, held by OTSUKA AMERICA PHARMACEUTICAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic dextromethorphan and quinidine

Approved generic versions of Nuedexta
Company	ANDA	TE code	Approved	Strengths
ACTAVIS ELIZABETH LLC	202934	AB (A-rated, therapeutically equivalent)	October 10, 2017	20MG;10MG
HETERO LABS LTD UNIT III	218426	AB (A-rated, therapeutically equivalent)	August 28, 2024	20MG;10MG
SUN PHARMACEUTICAL INDUSTRIES LTD	204196	AB (A-rated, therapeutically equivalent)	June 3, 2026	20MG;10MG

Nuedexta patents

Patents listed for Nuedexta
Patent	Expires	Covers	Use code	NDA
7659282	August 13, 2026	Method of use	U-1093	021879

Nuedexta NDC codes

Questions

Is there a generic for Nuedexta?

Yes. The generic name for Nuedexta is dextromethorphan and quinidine. 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 Nuedexta?

The active ingredient in Nuedexta is dextromethorphan and quinidine, per the FDA Orange Book.

When does the Nuedexta patent expire?

The last patent listed for Nuedexta in the Orange Book expires August 13, 2026. A listed patent expiry date is not a generic launch date.

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.