Is there a generic for Dextromethorphan polistirex?

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

What is the reference-listed drug for Dextromethorphan polistirex?

DELSYM (NDA 018658, RB HLTH) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Dextromethorphan polistirex are approved?

Dextromethorphan polistirex is approved in the following dosage form: suspension, extended release.

FDA Orange Book · active-ingredient family

Dextromethorphan polistirex

Dextromethorphan polistirex is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DELSYM · NDA 018658

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · suspension, extended release

Product	Applicant	Application	TE	Approved
DELSYMRLD	RB HLTH	NDA 018658	—	Oct 08, 1982

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
DEXTROMETHORPHAN POLISTIREX	AUROBINDO PHARMA LTD	ANDA 218417	—	Apr 15, 2026
DEXTROMETHORPHAN POLISTIREX	AMNEAL	ANDA 203133	—	Jul 28, 2017
DEXTROMETHORPHAN POLISTIREX	TRIS PHARMA INC	ANDA 091135	—	May 25, 2012

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Dextromethorphan polistirex — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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