Is there a generic for Bisoprolol fumarate; hydrochlorothiazide?

Yes. The FDA Orange Book lists 15 approved generic (ANDA) applications for Bisoprolol fumarate; hydrochlorothiazide, referencing the brand ZIAC. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Bisoprolol fumarate; hydrochlorothiazide?

ZIAC (NDA 020186, TEVA BRANDED PHARM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Bisoprolol fumarate; hydrochlorothiazide are approved?

Bisoprolol fumarate; hydrochlorothiazide is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Bisoprolol fumarate; hydrochlorothiazide

Bisoprolol fumarate; hydrochlorothiazide is approved as 1 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ZIAC · NDA 020186

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
ZIACRLD×3	TEVA BRANDED PHARM	NDA 020186	AB	Mar 26, 1993

Generic (ANDA) products (15)

Product	Applicant	Application	TE	Approved
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE×3	UNIQUE PHARM	ANDA 219489	AB	Mar 24, 2026
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE×3	AUROBINDO PHARMA LTD	ANDA 217922	AB	Jan 21, 2026
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE×3	CADILA	ANDA 215666	AB	Nov 04, 2022
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE×3	GLENMARK PHARMS LTD	ANDA 215995	AB	Jan 26, 2022
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE×3	NOVITIUM PHARMA	ANDA 215562	AB	Nov 04, 2021
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE×3	EDENBRIDGE PHARMS	ANDA 212678	AB	Jul 09, 2020
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE×3	UNICHEM	ANDA 079106	AB	Jul 28, 2010
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE×3	TEVA	ANDA 075686	—	Jan 19, 2001
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE×3	APOTHECON	ANDA 075642	—	Dec 27, 2000
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE×3	IVAX SUB TEVA PHARMS	ANDA 075632	—	Sep 27, 2000
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE×3	ACTAVIS ELIZABETH	ANDA 075672	—	Sep 25, 2000
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE×3	CHARTWELL RX	ANDA 075527	—	Sep 25, 2000
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE×3	EPIC PHARMA LLC	ANDA 075579	AB	Sep 25, 2000
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE×3	MYLAN	ANDA 075768	AB	Sep 25, 2000
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE×3	WATSON LABS TEVA	ANDA 075469	—	Sep 25, 2000

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.

Bisoprolol fumarate; hydrochlorothiazide — frequently asked questions

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

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