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 6 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	d9892176-d4a6-4edb-92b9-5f56243f3d22	2016-06-13	Warnings, Adverse reactions	Exact identifier rxcui: 905222 unii: FD171B778Y
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	ddbbdb09-3202-42d7-bbb0-08331dde2f54	2016-02-29	Warnings, Adverse reactions	Exact identifier application number: ANDA089097 application number: ANDA088467 application number: ANDA088468 ndc (product): 50111-398 ndc (product): 50111-327 ndc (product): 50111-328 rxcui: 905225 rxcui: 905199 rxcui: 905395 rxcui: 905222 spl id: faf6c313-03e6-4bf8-ac9f-65642ae10097 spl set id: ddbbdb09-3202-42d7-bbb0-08331dde2f54 unii: FD171B778Y

Reported adverse events (FAERS/openFDA)#

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