FDA.reportPublic FDA data

NDC 70518-2551-01 - 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
70518-2551
Requested NDC
70518-2551-01
Package NDCs from labels
70518-2551-0, 70518-2551-1, 70518-2551-2, 70518-2551-3, 70518-2551-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-02-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HYDRALAZINE HYDROCHLORIDE TABLETS, USPREMEDYREPACK INC.2026-02-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2551-0Hydralazine Hydrochloride30 in 1 BLISTER PACKTABLET3013
70518-2551-1Hydralazine Hydrochloride30 in 1 BLISTER PACKTABLET3013
70518-2551-2Hydralazine Hydrochloride180 in 1 BOTTLE, PLASTICTABLET18013
70518-2551-3Hydralazine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET9013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2551HYDRALAZINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 4 package rows20250501_89afc8ef-27c4-489a-81de-3f8f65f6bbb8.zip

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 5 · 99 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
application number: ANDA040901
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
rxcui: 905225
unii: FD171B778Y
HydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC921c8693-84c2-4313-a2a6-ab3be637d5542016-07-14Warnings, Adverse reactionsExact identifier
rxcui: 905222
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd9892176-d4a6-4edb-92b9-5f56243f3d222016-06-13Warnings, Adverse reactionsExact identifier
rxcui: 905222
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.ddbbdb09-3202-42d7-bbb0-08331dde2f542016-02-29Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905199
rxcui: 905395
rxcui: 905222
unii: FD171B778Y

Reported adverse events (FAERS/openFDA)#

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