FDA.reportPublic FDA data

NDC 48433-048-01 - 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
48433-048
Requested NDC
48433-048-01
Package NDCs from labels
48433-048-01, 48433-048-20
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-09-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydralazine Hydrochloride - Cardinal Health 107, LLCCardinal Health 107, LLC2026-09-14HUMAN PRESCRIPTION DRUG LABEL
Hydralazine Hydrochloride - Safecor Health, LLCSafecor Health, LLC2026-03-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48433-048-01Hydralazine Hydrochloride1 in 1 BLISTER PACKTABLET12
48433-048-20Hydralazine Hydrochloride100 in 1 CARTONTABLET1002

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 4ELV7Z65AP
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEA-S Medication Solutionse617023e-b060-4db9-a97e-e2b11a37901e2023-08-28Warnings, Adverse reactionsExact identifier
application number: ANDA088468
rxcui: 905395
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack62475f78-5410-43c2-a11d-54a8363c3ae12023-07-25Warnings, Adverse reactionsExact identifier
rxcui: 905395
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEMedical Purchasing Solutions, LLC7979c865-737d-d999-e053-2a91aa0abc5e2023-05-16Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
HydrALAZINE hydrochlorideHYDRALAZINE HYDROCHLORIDEMedical Purchasing Solutions, LLCd89d981d-64cf-7321-e053-2995a90aab4a2023-05-03Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEMedical Purchasing Solutions, LLCdd2cd8a1-7bdd-05e4-e053-2995a90ad3662023-05-02Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDECadila Pharmaceuticals Limited3a7562a8-2f67-4411-ac4a-ab7924193e822022-12-29Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905395
rxcui: 905222
unii: FD171B778Y
hydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEFresenius Kabi USA, LLCc3797028-c625-4f70-ae69-8a5f6f23f1b82022-08-09Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEFresenius Kabi USA, LLC8223c44a-73a9-4da5-a468-d1d8bdb0bbd62022-05-18Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
isosorbide dinitrate and hydralazine hydrochlorideHYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATEWilshire Pharmaceuticals620a0680-aad0-4923-84be-7393c0cbdcbd2022-04-14Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDERadha Pharmaceuticals, Inc.149fa857-30ad-451d-b6e2-0000483ccc972021-03-12Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905199
rxcui: 905395
rxcui: 905222
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEScieGen Pharmaceuticals, Inc.500b7f76-5f4e-4e7d-85c3-18b9f66d75042021-03-04Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905199
rxcui: 905395
rxcui: 905222
unii: FD171B778Y
HydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEExelan Pharmaceuticals Inc.811831f9-a844-463a-874d-fb8407659f0b2020-09-04Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905199
rxcui: 905395
rxcui: 905222
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEProficient Rx LP63f388e0-9f3d-4902-990c-9a105aa098ad2020-09-01Warnings, Adverse reactionsExact identifier
rxcui: 905225
unii: FD171B778Y
HydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEProficient Rx LPdfd60a79-2a30-41e6-b000-a144730099a82019-10-01Warnings, Adverse reactionsExact identifier
rxcui: 905395
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEProficient Rx LP48cf71dd-19dc-4239-9117-ebcf9731a45d2019-10-01Warnings, Adverse reactionsExact identifier
rxcui: 905199
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEAmerican Regent, Inc.17210abc-58f6-442e-8ff2-7971333c82f62019-05-06Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEAscend Laboratories, LLCe7bfec3d-5222-4a26-8f99-6c2a28e14aa62017-12-28Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905199
rxcui: 905395
rxcui: 905222
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCbfbd5960-ae6b-46f5-adfa-e330d7a21dfa2017-12-21Warnings, Adverse reactionsExact identifier
application number: ANDA088467
rxcui: 905225
unii: FD171B778Y
HydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC921c8693-84c2-4313-a2a6-ab3be637d5542016-07-14Warnings, Adverse reactionsExact identifier
rxcui: 905222
unii: FD171B778Y

Reported adverse events (FAERS/openFDA)#

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