Is there a generic for Fexofenadine hydrochloride; pseudoephedrine hydrochloride?

Yes. The FDA Orange Book lists 9 approved generic (ANDA) applications for Fexofenadine hydrochloride; pseudoephedrine hydrochloride, referencing the brand ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Fexofenadine hydrochloride; pseudoephedrine hydrochloride?

ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION (NDA 020786, CHATTEM SANOFI) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

FDA Orange Book · active-ingredient family

Fexofenadine hydrochloride; pseudoephedrine hydrochloride

Fexofenadine hydrochloride; pseudoephedrine hydrochloride is approved as 2 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION · NDA 020786

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet, extended release

Product	Applicant	Application	TE	Approved
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTIONRLD	CHATTEM SANOFI	NDA 020786	—	Jan 24, 2011
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTIONRLD	CHATTEM SANOFI	NDA 021704	—	Jan 24, 2011

Generic (ANDA) products (9)

Product	Applicant	Application	TE	Approved
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	L PERRIGO CO	ANDA 216792	—	Oct 07, 2025
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	AUROBINDO PHARMA LTD	ANDA 215232	—	Apr 17, 2025
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	DR REDDYS	ANDA 215434	—	May 31, 2022
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	AUROBINDO PHARMA	ANDA 209116	—	Oct 30, 2017
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	SUN PHARM	ANDA 090818	—	Jan 29, 2015
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	DR REDDYS	ANDA 076667	—	Nov 18, 2014
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	DR REDDYS LABS LTD	ANDA 079043	—	Jun 22, 2011
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	IMPAX PHARMS	ANDA 076298	—	Nov 12, 2010
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	BARR	ANDA 076236	—	Apr 14, 2005

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.