NDC 65977-219 - 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: 65977-219
Package NDCs from labels: 65977-219-10, 65977-219-50, 65977-219-01
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
65977-219-01	HYDRALAZINE HYDROCHLORIDE	1000 in 1 BOTTLE	TABLET	1000	1
65977-219-10	HYDRALAZINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET	100	1
65977-219-50	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
65977-219	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 3 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	Bryant Ranch Prepack	90c18c55-3045-4a10-a2bb-012e4a5e1564	2025-03-25	Warnings, Adverse reactions	Exact identifier application number: ANDA040901 rxcui: 905395 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	5da36930-d3da-4b5c-9e22-2b141bc01a9c	2025-03-13	Warnings, Adverse reactions	Exact identifier application number: ANDA040901 rxcui: 905225 rxcui: 905199 rxcui: 905395 rxcui: 905222 unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Baxter Healthcare Corporation	f1a10203-f027-4f9c-8dd6-907c6db24d47	2025-03-10	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
YVTYVT MICRODERMABRASION FACIAL SCRUB	YVTYVT MICRODERMABRASION FACIAL SCRUB	Beijing JUNGE Technology Co., Ltd.	2f30fc45-42e2-c766-e063-6394a90a8d68	2025-02-28	Warnings	Exact identifier unii: OP1R32D61U
isosorbide dinitrate and hydralazine hydrochloride	ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	A2A Integrated Pharmaceuticals	ae757a78-89e8-4f79-81de-d558db3f72a4	2025-02-28	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Coupler LLC	2e9688ef-781c-aead-e063-6294a90a7bca	2025-02-20	Warnings, Adverse reactions	Exact identifier rxcui: 905199 unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Coupler LLC	2df51a19-a39a-0ec8-e063-6394a90a147c	2025-02-12	Warnings, Adverse reactions	Exact identifier rxcui: 905395 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Proficient Rx LP	775e99c4-e18d-4648-a0e3-8709950249ff	2025-02-01	Warnings, Adverse reactions	Exact identifier application number: ANDA040901 rxcui: 905222 unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	94530e4d-b1c0-6171-e053-2a95a90a05fa	2025-01-08	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	7ae650f7-a481-4637-a9a2-9bda43a5a288	2024-12-24	Warnings, Adverse reactions	Exact identifier rxcui: 905225 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	a862321d-ebc1-7676-e053-2995a90a5861	2024-12-17	Warnings, Adverse reactions	Exact identifier application number: ANDA040901 rxcui: 905222 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	ff2c4d1e-33ee-40d7-955b-d736f0559f39	2024-12-03	Warnings, Adverse reactions	Exact identifier rxcui: 905225 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	10f3e76e-9bba-4151-89fb-90d823a0a68c	2024-11-08	Warnings, Adverse reactions	Exact identifier rxcui: 905225 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	American Health Packaging	2e82655e-8435-46fa-b734-8e7c6e803453	2024-09-23	Warnings, Adverse reactions	Exact identifier rxcui: 905225 rxcui: 905199 rxcui: 905395 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Macleods Pharmaceuticals Limited	f9f56326-6d72-47d3-89ac-3625b8a6d713	2024-09-06	Warnings, Adverse reactions	Exact identifier rxcui: 905225 rxcui: 905199 rxcui: 905395 rxcui: 905222 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	f07abdec-6d94-45b6-be1b-10a898ea28c2	2024-08-12	Warnings, Adverse reactions	Exact identifier application number: ANDA040901 rxcui: 905222 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	A-S Medication Solutions	8ade1ffe-3738-4aa1-b9c7-59f7290600b9	2024-08-07	Warnings, Adverse reactions	Exact identifier rxcui: 905395 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	A-S Medication Solutions	a8194ac4-02d5-4aa1-b4e4-a3759f6f64b5	2024-08-07	Warnings, Adverse reactions	Exact identifier rxcui: 905395 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	3b61d1b0-c699-67a8-e054-00144ff88e88	2024-07-16	Warnings, Adverse reactions	Exact identifier application number: ANDA040901 rxcui: 905199 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4b7d3378-86f8-0a5f-e054-00144ff8d46c	2024-07-15	Warnings, Adverse reactions	Exact identifier application number: ANDA040901 rxcui: 905395 unii: FD171B778Y

Reported adverse events (FAERS/openFDA)#

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