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 1 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	51c293c1-70e7-48c7-8af1-a8b74312ed56	2026-09-08	Warnings, Adverse reactions	Exact identifier rxcui: 905222 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	6c40d818-77a9-492c-b9b6-d8a0fe8d6736	2026-08-27	Warnings, Adverse reactions	Exact identifier rxcui: 905225 unii: FD171B778Y
hydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	dca82025-a4cd-4856-aa19-bdf091bf8973	2026-08-14	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	d2d98842-ff32-4a61-94e0-60e06919948f	2026-08-14	Warnings, Adverse reactions	Exact identifier application number: ANDA040901 rxcui: 905225 rxcui: 905222 unii: FD171B778Y
HydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Coupler LLC	58773e8c-b6bc-6bc6-e063-6294a90adc26	2026-08-07	Warnings, Adverse reactions	Exact identifier rxcui: 905395 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	db7500f3-f8a6-46b1-bb64-9727617a9643	2026-07-30	Warnings, Adverse reactions	Exact identifier rxcui: 905225 rxcui: 905395 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Major Pharmaceuticals	b6ccd35e-f69c-4eef-a456-905e030ae911	2026-07-15	Warnings, Adverse reactions	Exact identifier rxcui: 905225 rxcui: 905199 rxcui: 905395 rxcui: 905222 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Northwind Health Company, LLC	1275dd50-d97f-2e8f-e063-6394a90a4a67	2026-06-22	Warnings, Adverse reactions	Exact identifier rxcui: 905225 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	8b7e88ef-5edd-40df-8e43-e3f29970be58	2026-06-19	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	d61ffa06-8138-4a1d-9530-095a80d9c9ce	2026-06-12	Warnings, Adverse reactions	Exact identifier rxcui: 905395 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	a70d20d6-23f0-477e-915c-678a86782175	2026-06-12	Warnings, Adverse reactions	Exact identifier rxcui: 905199 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	0d65e146-83e5-427f-ac06-04c0d8e72cea	2026-06-09	Warnings, Adverse reactions	Exact identifier rxcui: 905225 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	43ce0ecb-6d62-44bf-8539-823ae03eb9f4	2026-06-03	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	a1066707-2391-4918-8ded-600c017fde48	2026-05-18	Warnings, Adverse reactions	Exact identifier rxcui: 905225 rxcui: 905395 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	438479d0-ff61-4008-a0fc-1ee44b97cf7f	2026-05-07	Warnings, Adverse reactions	Exact identifier application number: ANDA040901 rxcui: 905222 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	f0db9c3c-d841-46f9-8409-9ffca83d7a97	2026-05-06	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Navinta LLC	ae5d85df-11a3-4952-ade2-596d57cdd987	2026-04-21	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	669532c9-ba15-4f4b-95a8-13782deb3521	2026-04-03	Warnings, Adverse reactions	Exact identifier rxcui: 905225 rxcui: 905199 rxcui: 905395 rxcui: 905222 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Safecor Health, LLC	66c5eaa4-a51a-464b-98ad-f094f32876dd	2026-03-11	Warnings, Adverse reactions	Exact identifier rxcui: 905225 rxcui: 905199 rxcui: 905395 unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Meitheal Pharmaceuticals Inc.	f3c806a4-b971-421c-bcb9-9979c6d7aaec	2026-02-27	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y

Reported adverse events (FAERS/openFDA)#

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