FDA.reportPublic FDA data

NDC 63629-5246-01 - 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
63629-5246
Requested NDC
63629-5246-01
Package NDCs from labels
63629-5246-1, 63629-5246-2, 63629-5246-3, 63629-5246-4, 63629-5246-01
Manufacturer
Bryant Ranch Prepack
Effective date
2025-03-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydralazine Hydrochloride - Bryant Ranch PrepackBryant Ranch Prepack2025-03-25Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-5246-1Hydralazine Hydrochloride30 in 1 BOTTLETABLET301008
63629-5246-2Hydralazine Hydrochloride60 in 1 BOTTLETABLET601008
63629-5246-3Hydralazine Hydrochloride120 in 1 BOTTLETABLET1201008
63629-5246-4Hydralazine Hydrochloride90 in 1 BOTTLETABLET901008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5246HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1008Current NDC, Legacy NDC, 4 package rows20250327_90c18c55-3045-4a10-a2bb-012e4a5e1564.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000

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 · 102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack90c18c55-3045-4a10-a2bb-012e4a5e15642025-03-25Warnings, Adverse reactionsExact identifier
application number: ANDA040901
ndc (package): 63629-5246-4
ndc (package): 63629-5246-2
ndc (package): 63629-5246-1
ndc (package): 63629-5246-3
ndc (product): 63629-5246
ndc11 (package): 63629524601
rxcui: 905395
spl id: 608758ea-f449-4ae7-895e-0c8c2b88cc38
spl set id: 90c18c55-3045-4a10-a2bb-012e4a5e1564
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECamber Pharmaceuticals, Inc.5da36930-d3da-4b5c-9e22-2b141bc01a9c2025-03-13Warnings, Adverse reactionsExact identifier
application number: ANDA040901
ndc (product): 31722-521
rxcui: 905225
rxcui: 905199
rxcui: 905395
rxcui: 905222
spl id: 30381b85-deb3-bc70-e063-6294a90ad921
spl set id: 5da36930-d3da-4b5c-9e22-2b141bc01a9c
unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEBaxter Healthcare Corporationf1a10203-f027-4f9c-8dd6-907c6db24d472025-03-10Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
isosorbide dinitrate and hydralazine hydrochlorideISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDEA2A Integrated Pharmaceuticalsae757a78-89e8-4f79-81de-d558db3f72a42025-02-28Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECoupler LLC2e9688ef-781c-aead-e063-6294a90a7bca2025-02-20Warnings, Adverse reactionsExact identifier
rxcui: 905199
unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDECoupler LLC2df51a19-a39a-0ec8-e063-6394a90a147c2025-02-12Warnings, Adverse reactionsExact identifier
rxcui: 905395
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEProficient Rx LP775e99c4-e18d-4648-a0e3-8709950249ff2025-02-01Warnings, Adverse reactionsExact identifier
application number: ANDA040901
rxcui: 905222
unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst94530e4d-b1c0-6171-e053-2a95a90a05fa2025-01-08Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack7ae650f7-a481-4637-a9a2-9bda43a5a2882024-12-24Warnings, Adverse reactionsExact identifier
rxcui: 905225
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.a862321d-ebc1-7676-e053-2995a90a58612024-12-17Warnings, Adverse reactionsExact identifier
application number: ANDA040901
rxcui: 905222
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepackff2c4d1e-33ee-40d7-955b-d736f0559f392024-12-03Warnings, Adverse reactionsExact identifier
rxcui: 905225
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack10f3e76e-9bba-4151-89fb-90d823a0a68c2024-11-08Warnings, Adverse reactionsExact identifier
rxcui: 905225
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEAmerican Health Packaging2e82655e-8435-46fa-b734-8e7c6e8034532024-09-23Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905199
rxcui: 905395
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEMacleods Pharmaceuticals Limitedf9f56326-6d72-47d3-89ac-3625b8a6d7132024-09-06Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905199
rxcui: 905395
rxcui: 905222
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsf07abdec-6d94-45b6-be1b-10a898ea28c22024-08-12Warnings, Adverse reactionsExact identifier
application number: ANDA040901
rxcui: 905222
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEA-S Medication Solutions8ade1ffe-3738-4aa1-b9c7-59f7290600b92024-08-07Warnings, Adverse reactionsExact identifier
rxcui: 905395
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEA-S Medication Solutionsa8194ac4-02d5-4aa1-b4e4-a3759f6f64b52024-08-07Warnings, Adverse reactionsExact identifier
rxcui: 905395
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.3b61d1b0-c699-67a8-e054-00144ff88e882024-07-16Warnings, Adverse reactionsExact identifier
application number: ANDA040901
rxcui: 905199
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.4b7d3378-86f8-0a5f-e054-00144ff8d46c2024-07-15Warnings, Adverse reactionsExact identifier
application number: ANDA040901
rxcui: 905395
unii: FD171B778Y

Reported adverse events (FAERS/openFDA)#

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