NDC 48433-047-01 - 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: 48433-047
Requested NDC: 48433-047-01
Package NDCs from labels: 48433-047-01, 48433-047-20
Manufacturer: Safecor Health, LLC
Effective date: 2026-03-11
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 - Safecor Health, LLC	Safecor Health, LLC	2026-03-11	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
48433-047-01	Hydralazine Hydrochloride	1 in 1 BLISTER PACK	TABLET	1		2
48433-047-20	Hydralazine Hydrochloride	100 in 1 CARTON	TABLET	100		2

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 5 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anubis Barcelona Spa Line	ORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACID	ANUBIS COSMETICS SL	eb01a962-ab38-18ec-e053-2995a90acdeb	2023-09-01	Warnings	Exact identifier unii: 4ELV7Z65AP
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	A-S Medication Solutions	e617023e-b060-4db9-a97e-e2b11a37901e	2023-08-28	Warnings, Adverse reactions	Exact identifier application number: ANDA088468 rxcui: 905395 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	62475f78-5410-43c2-a11d-54a8363c3ae1	2023-07-25	Warnings, Adverse reactions	Exact identifier rxcui: 905395 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	7979c865-737d-d999-e053-2a91aa0abc5e	2023-05-16	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
HydrALAZINE hydrochloride	HYDRALAZINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	d89d981d-64cf-7321-e053-2995a90aab4a	2023-05-03	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	dd2cd8a1-7bdd-05e4-e053-2995a90ad366	2023-05-02	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Cadila Pharmaceuticals Limited	3a7562a8-2f67-4411-ac4a-ab7924193e82	2022-12-29	Warnings, Adverse reactions	Exact identifier rxcui: 905225 rxcui: 905395 rxcui: 905222 unii: FD171B778Y
hydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	c3797028-c625-4f70-ae69-8a5f6f23f1b8	2022-08-09	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	8223c44a-73a9-4da5-a468-d1d8bdb0bbd6	2022-05-18	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
isosorbide dinitrate and hydralazine hydrochloride	HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE	Wilshire Pharmaceuticals	620a0680-aad0-4923-84be-7393c0cbdcbd	2022-04-14	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Radha Pharmaceuticals, Inc.	149fa857-30ad-451d-b6e2-0000483ccc97	2021-03-12	Warnings, Adverse reactions	Exact identifier rxcui: 905225 rxcui: 905199 rxcui: 905395 rxcui: 905222 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	ScieGen Pharmaceuticals, Inc.	500b7f76-5f4e-4e7d-85c3-18b9f66d7504	2021-03-04	Warnings, Adverse reactions	Exact identifier rxcui: 905225 rxcui: 905199 rxcui: 905395 rxcui: 905222 unii: FD171B778Y
HydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Exelan Pharmaceuticals Inc.	811831f9-a844-463a-874d-fb8407659f0b	2020-09-04	Warnings, Adverse reactions	Exact identifier rxcui: 905225 rxcui: 905199 rxcui: 905395 rxcui: 905222 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Proficient Rx LP	63f388e0-9f3d-4902-990c-9a105aa098ad	2020-09-01	Warnings, Adverse reactions	Exact identifier rxcui: 905225 unii: FD171B778Y
HydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Proficient Rx LP	dfd60a79-2a30-41e6-b000-a144730099a8	2019-10-01	Warnings, Adverse reactions	Exact identifier rxcui: 905395 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Proficient Rx LP	48cf71dd-19dc-4239-9117-ebcf9731a45d	2019-10-01	Warnings, Adverse reactions	Exact identifier rxcui: 905199 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	American Regent, Inc.	17210abc-58f6-442e-8ff2-7971333c82f6	2019-05-06	Warnings, Adverse reactions	Exact identifier unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Ascend Laboratories, LLC	e7bfec3d-5222-4a26-8f99-6c2a28e14aa6	2017-12-28	Warnings, Adverse reactions	Exact identifier rxcui: 905225 rxcui: 905199 rxcui: 905395 rxcui: 905222 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	bfbd5960-ae6b-46f5-adfa-e330d7a21dfa	2017-12-21	Warnings, Adverse reactions	Exact identifier application number: ANDA088467 rxcui: 905225 unii: FD171B778Y
HydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	921c8693-84c2-4313-a2a6-ab3be637d554	2016-07-14	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.