Last Updated: May 10, 2026

Suppliers and packagers for HYDRALAZINE HYDROCHLORIDE

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HYDRALAZINE HYDROCHLORIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Am Regent	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	INJECTABLE;INJECTION	040136	ANDA	American Regent, Inc.	0517-0901-25	25 VIAL, SINGLE-DOSE in 1 TRAY (0517-0901-25) / 1 mL in 1 VIAL, SINGLE-DOSE	1997-06-30
Am Regent	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	INJECTABLE;INJECTION	040136	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1648-3	25 POUCH in 1 CASE (51662-1648-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1648-2) / 1 mL in 1 VIAL, SINGLE-DOSE	1997-06-30
Am Regent	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	INJECTABLE;INJECTION	040136	ANDA	Civica, Inc.	72572-265-25	25 VIAL, SINGLE-DOSE in 1 TRAY (72572-265-25) / 1 mL in 1 VIAL, SINGLE-DOSE (72572-265-01)	2020-10-29
Baxter Hlthcare Corp	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	INJECTABLE;INJECTION	219797	ANDA	Baxter Healthcare Corporation	43066-041-25	25 VIAL, SINGLE-DOSE in 1 CARTON (43066-041-25) / 1 mL in 1 VIAL, SINGLE-DOSE (43066-041-01)	2025-07-17
Eugia Pharma	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	INJECTABLE;INJECTION	215147	ANDA	Eugia US LLC	55150-400-25	25 VIAL, SINGLE-DOSE in 1 CARTON (55150-400-25) / 1 mL in 1 VIAL, SINGLE-DOSE	2023-02-13
Eugia Pharma	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	INJECTABLE;INJECTION	215147	ANDA	Medical Purchasing Solutions, LLC	71872-7339-1	1 VIAL, SINGLE-DOSE in 1 BAG (71872-7339-1) / 1 mL in 1 VIAL, SINGLE-DOSE	2023-02-13
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

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