NDC 65977-221 - HYDRALAZINE HYDROCHLORIDE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 65977-221
Package NDCs from labels: 65977-221-10, 65977-221-50, 65977-221-01
Manufacturer: Rebel Distributors Corp
Effective date: 2011-01-17
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
HYDRALAZINE HYDROCHLORIDE - Rebel Distributors Corp	Rebel Distributors Corp	2011-01-17	HUMAN PRESCRIPTION DRUG LABEL
HYDRALAZINE HYDROCHLORIDE - HETERO DRUGS LIMITED	HETERO DRUGS LIMITED	2008-09-19	HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65977-221-01	HYDRALAZINE HYDROCHLORIDE	1000 in 1 BOTTLE	TABLET	1000	1
65977-221-10	HYDRALAZINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET	100	1
65977-221-50	HYDRALAZINE HYDROCHLORIDE	500 in 1 BOTTLE	TABLET	500	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65977-221	HYDRALAZINE HYDROCHLORIDE TABLET [HETERO DRUGS LIMITED]	1	3 package rows	20081030_a2b73026-2451-406f-b866-9dc16177cb44.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Hydralazine hydrochloride	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
Hydralazine	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
Anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	HYDRALAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDRALAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDRALAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDRALAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
Stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	HYDRALAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
Hydralazine hydrochloride	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE TABLET [HETERO DRUGS LIMITED]	1
Hydralazine	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE TABLET [HETERO DRUGS LIMITED]	1
Anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	HYDRALAZINE HYDROCHLORIDE TABLET [HETERO DRUGS LIMITED]	1
FD&C Yellow # 6	INACTIVE INGREDIENT		HYDRALAZINE HYDROCHLORIDE TABLET [HETERO DRUGS LIMITED]	1
Microcrystalline cellulose	INACTIVE INGREDIENT	OP1R32D61U	HYDRALAZINE HYDROCHLORIDE TABLET [HETERO DRUGS LIMITED]	1
Sodium starch glycolate	INACTIVE INGREDIENT		HYDRALAZINE HYDROCHLORIDE TABLET [HETERO DRUGS LIMITED]	1
Stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	HYDRALAZINE HYDROCHLORIDE TABLET [HETERO DRUGS LIMITED]	1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Coupler LLC	4aa1b3e8-9389-fe2c-e063-6294a90a7fb9	2026-02-12	Warnings, Adverse reactions	Exact identifier rxcui: 905225 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	89afc8ef-27c4-489a-81de-3f8f65f6bbb8	2026-02-09	Warnings, Adverse reactions	Exact identifier application number: ANDA040901 rxcui: 905225 unii: FD171B778Y
HydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Strides Pharma Science Limited	b3d1786d-c3ff-42f1-a09f-37a9c9021e5a	2026-02-02	Warnings, Adverse reactions	Exact identifier rxcui: 905225 rxcui: 905199 rxcui: 905395 rxcui: 905222 unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	e9450e82-329f-4fd8-a0b3-3e8e22715965	2026-01-07	Warnings, Adverse reactions	Exact identifier rxcui: 905395 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	bf1b7c2f-535c-45bb-928a-65606d87685e	2025-12-16	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Chartwell RX, LLC	0c7f9bd0-6c0a-4521-b77a-3582faa96874	2025-12-10	Warnings, Adverse reactions	Exact identifier rxcui: 905225 rxcui: 905199 rxcui: 905395 rxcui: 905222 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	A-S Medication Solutions	7253aaa0-e272-499f-9bfa-304e9556a8fb	2025-12-05	Warnings, Adverse reactions	Exact identifier application number: ANDA040901 rxcui: 905395 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	A-S Medication Solutions	f16f1d87-f9e6-4555-9baf-26ff17cb1d28	2025-12-05	Warnings, Adverse reactions	Exact identifier application number: ANDA040901 rxcui: 905225 rxcui: 905395 unii: FD171B778Y
BiDil	HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE	Azurity Pharmaceuticals, Inc.	e1e63cd5-d1e4-4af5-bad5-1ad41ea46b00	2025-11-30	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	f34904dc-c945-4de4-8594-34e4f4ac1983	2025-11-28	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Eugia US LLC	e08d8b6c-a184-4dd5-84ef-bac90e4b1c33	2025-11-11	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	336b11da-e592-4386-921f-3c136d754f2a	2025-11-06	Warnings, Adverse reactions	Exact identifier rxcui: 905225 rxcui: 905395 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Coupler LLC	41c019e3-7b07-5f12-e063-6294a90a5365	2025-10-22	Warnings, Adverse reactions	Exact identifier rxcui: 905199 unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	3f8fb1fc-ffef-4f94-e063-6294a90a2b82	2025-09-24	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Mylan Institutional Inc.	493a8b7e-5bb1-4db2-91a7-77ed87864131	2025-07-22	Warnings, Adverse reactions	Exact identifier rxcui: 905225 rxcui: 905199 rxcui: 905395 unii: FD171B778Y
hydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	ProPharma Distribution	3855c3da-ff25-8301-e063-6294a90a22b3	2025-07-18	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Proficient Rx LP	024ac6b8-5ce0-4435-9b11-b1806c511d7b	2025-07-01	Warnings, Adverse reactions	Exact identifier rxcui: 905225 unii: FD171B778Y
Isosorbide dinitrate and hydralazine hydrochloride	ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	Ingenus Pharmaceuticals, LLC	8f54d5a3-169f-48dd-9250-2c176d2bd9ad	2025-06-03	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Henry Schein, Inc.	4d1f55aa-e924-4540-ae9f-bd7362a82f33	2025-05-20	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	a79ddc89-546b-4808-879d-c0f592141636	2025-03-31	Warnings, Adverse reactions	Exact identifier application number: ANDA040901 rxcui: 905199 unii: FD171B778Y

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.