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 4 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
isosorbide dinitrate and hydralazine hydrochloride	HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE	Bryant Ranch Prepack	2a6fe05a-fcd4-42d1-bf5d-1d39ac273363	2024-07-01	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	37ba0233-ed75-498a-a067-6220da573653	2024-05-24	Warnings, Adverse reactions	Exact identifier rxcui: 905225 rxcui: 905199 rxcui: 905395 rxcui: 905222 unii: FD171B778Y
isosorbide dinitrate and hydralazine hydrochloride	ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	i3 Pharmaceuticals, LLC	cacf1a7c-0388-09ee-e053-2995a90a10cf	2024-05-16	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Modavar Pharmaceuticals LLC	a456bc34-0c79-44f4-9119-50028a978f5f	2024-05-14	Warnings, Adverse reactions	Exact identifier rxcui: 905225 rxcui: 905395 rxcui: 905222 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Civica, Inc.	ffa483a4-de2a-4d42-ad27-afacd37f28e4	2024-04-28	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
HydrALAZINE hydrochloride	HYDRALAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	3f5f1204-d289-40e9-be84-a29352f64bfb	2024-04-10	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	15b0f03b-b5a2-c49d-e063-6394a90a5b15	2024-04-09	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	c2638ae6-a210-490f-8389-bbed6a3229c5	2024-04-03	Warnings, Adverse reactions	Exact identifier rxcui: 905225 rxcui: 905395 rxcui: 905222 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	8224aa3d-b1b9-40df-93fd-a91c6a158898	2024-02-20	Warnings, Adverse reactions	Exact identifier rxcui: 905225 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	bc37cf50-b18d-467e-bf67-3270faa8332e	2024-02-05	Warnings, Adverse reactions	Exact identifier rxcui: 905222 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	d5b0165e-9823-470a-8ed0-5c4c8722369d	2024-02-05	Warnings, Adverse reactions	Exact identifier rxcui: 905395 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	4d1594dc-376b-44bd-8c0e-5de731dfb7f9	2024-02-02	Warnings, Adverse reactions	Exact identifier rxcui: 905199 unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	9949407f-e410-7f47-e053-2995a90a7369	2024-01-30	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	18dd864f-1e27-4c98-8f21-eaded77a3ed6	2024-01-11	Warnings, Adverse reactions	Exact identifier rxcui: 905395 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	e6d4b15e-1407-4783-94e4-9971dea68221	2024-01-11	Warnings, Adverse reactions	Exact identifier rxcui: 905199 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	36499d4b-bcaf-4b49-aa2a-10c3e34550d0	2024-01-11	Warnings, Adverse reactions	Exact identifier rxcui: 905225 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	4985994c-23ab-4409-bab6-5a17db767f13	2024-01-11	Warnings, Adverse reactions	Exact identifier rxcui: 905199 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	162a0c00-4db8-4f8d-9686-be2f8449abd8	2024-01-11	Warnings, Adverse reactions	Exact identifier rxcui: 905222 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	914d5b62-6f9b-4665-8562-689367c36230	2023-12-14	Warnings, Adverse reactions	Exact identifier rxcui: 905199 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	d4509f69-e60e-4440-957b-5c2714480335	2023-11-27	Warnings, Adverse reactions	Exact identifier rxcui: 905222 unii: FD171B778Y

Reported adverse events (FAERS/openFDA)#

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