Question 1

Is there a generic for Dextromethorphan hydrobromide; quinidine sulfate?

Accepted Answer

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Dextromethorphan hydrobromide; quinidine sulfate, referencing the brand NUEDEXTA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Dextromethorphan hydrobromide; quinidine sulfate?

Accepted Answer

NUEDEXTA (NDA 021879, OTSUKA AMERICA PHARM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Dextromethorphan hydrobromide; quinidine sulfate?

Accepted Answer

The Orange Book lists 1 patent against Dextromethorphan hydrobromide; quinidine sulfate products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

What dosage forms of Dextromethorphan hydrobromide; quinidine sulfate are approved?

Accepted Answer

Dextromethorphan hydrobromide; quinidine sulfate is approved in the following dosage form: capsule.

Product	Applicant	Application	TE	Approved
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE	SUN PHARM	ANDA 204196	AB	Jun 03, 2026
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE	HETERO LABS LTD III	ANDA 218426	AB	Aug 28, 2024
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE	ACTAVIS ELIZABETH	ANDA 202934	AB	Oct 10, 2017

Dextromethorphan hydrobromide; quinidine sulfate

Brand (NDA) products · capsule

Generic (ANDA) products (3)

Listed patents (1)

Dextromethorphan hydrobromide; quinidine sulfate — frequently asked questions

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.