FDA.reportPublic FDA data

NDC 71335-1685-01 - 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
71335-1685
Requested NDC
71335-1685-01
Package NDCs from labels
71335-1685-1, 71335-1685-2, 71335-1685-3, 71335-1685-4, 71335-1685-01
Manufacturer
Bryant Ranch Prepack
Effective date
2025-03-31
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 Prepack2025-03-31Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1685-1Hydralazine Hydrochloride30 in 1 BOTTLETABLET308
71335-1685-2Hydralazine Hydrochloride60 in 1 BOTTLETABLET608
71335-1685-3Hydralazine Hydrochloride90 in 1 BOTTLETABLET908
71335-1685-4Hydralazine Hydrochloride100 in 1 BOTTLETABLET1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1685HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 4 package rows20250402_a79ddc89-546b-4808-879d-c0f592141636.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 2 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECoupler LLC4aa1b3e8-9389-fe2c-e063-6294a90a7fb92026-02-12Warnings, Adverse reactionsExact identifier
rxcui: 905225
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.89afc8ef-27c4-489a-81de-3f8f65f6bbb82026-02-09Warnings, Adverse reactionsExact identifier
application number: ANDA040901
rxcui: 905225
unii: FD171B778Y
HydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEStrides Pharma Science Limitedb3d1786d-c3ff-42f1-a09f-37a9c9021e5a2026-02-02Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905199
rxcui: 905395
rxcui: 905222
unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.e9450e82-329f-4fd8-a0b3-3e8e227159652026-01-07Warnings, Adverse reactionsExact identifier
rxcui: 905395
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEFresenius Kabi USA, LLCbf1b7c2f-535c-45bb-928a-65606d87685e2025-12-16Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEChartwell RX, LLC0c7f9bd0-6c0a-4521-b77a-3582faa968742025-12-10Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905199
rxcui: 905395
rxcui: 905222
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEA-S Medication Solutions7253aaa0-e272-499f-9bfa-304e9556a8fb2025-12-05Warnings, Adverse reactionsExact identifier
application number: ANDA040901
rxcui: 905395
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEA-S Medication Solutionsf16f1d87-f9e6-4555-9baf-26ff17cb1d282025-12-05Warnings, Adverse reactionsExact identifier
application number: ANDA040901
rxcui: 905225
rxcui: 905395
unii: FD171B778Y
BiDilHYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATEAzurity Pharmaceuticals, Inc.e1e63cd5-d1e4-4af5-bad5-1ad41ea46b002025-11-30Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEFresenius Kabi USA, LLCf34904dc-c945-4de4-8594-34e4f4ac19832025-11-28Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEEugia US LLCe08d8b6c-a184-4dd5-84ef-bac90e4b1c332025-11-11Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECardinal Health 107, LLC336b11da-e592-4386-921f-3c136d754f2a2025-11-06Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905395
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECoupler LLC41c019e3-7b07-5f12-e063-6294a90a53652025-10-22Warnings, Adverse reactionsExact identifier
rxcui: 905199
unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEMedical Purchasing Solutions, LLC3f8fb1fc-ffef-4f94-e063-6294a90a2b822025-09-24Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEMylan Institutional Inc.493a8b7e-5bb1-4db2-91a7-77ed878641312025-07-22Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905199
rxcui: 905395
unii: FD171B778Y
hydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEProPharma Distribution3855c3da-ff25-8301-e063-6294a90a22b32025-07-18Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEProficient Rx LP024ac6b8-5ce0-4435-9b11-b1806c511d7b2025-07-01Warnings, Adverse reactionsExact identifier
rxcui: 905225
unii: FD171B778Y
Isosorbide dinitrate and hydralazine hydrochlorideISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDEIngenus Pharmaceuticals, LLC8f54d5a3-169f-48dd-9250-2c176d2bd9ad2025-06-03Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEHenry Schein, Inc.4d1f55aa-e924-4540-ae9f-bd7362a82f332025-05-20Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepacka79ddc89-546b-4808-879d-c0f5921416362025-03-31Warnings, Adverse reactionsExact identifier
application number: ANDA040901
ndc (package): 71335-1685-3
ndc (package): 71335-1685-2
ndc (package): 71335-1685-1
ndc (package): 71335-1685-4
ndc (product): 71335-1685
ndc11 (package): 71335168501
rxcui: 905199
spl id: 65e187b7-1f5e-438c-839d-5ea7cc947545
spl set id: a79ddc89-546b-4808-879d-c0f592141636
unii: FD171B778Y

Reported adverse events (FAERS/openFDA)#

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