FDA.reportPublic FDA data

NDC 72162-1535-01 - 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
72162-1535
Requested NDC
72162-1535-01
Package NDCs from labels
72162-1535-1, 72162-1535-0, 72162-1535-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-02-02
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 Prepack2024-02-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1535-0Hydralazine Hydrochloride1000 in 1 BOTTLETABLET1000100
72162-1535-1Hydralazine Hydrochloride100 in 1 BOTTLETABLET100100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1535HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20240206_4d1594dc-376b-44bd-8c0e-5de731dfb7f9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1535-0EA - Each72162-153562bce06d-c888-45b8-8c80-3fb930189d4e12024-03-12
72162-1535-1EA - Each72162-153525f3a100-3ae1-489d-a5cd-45d365a7a10512024-03-12

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
application number: ANDA205236
rxcui: 905225
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.89afc8ef-27c4-489a-81de-3f8f65f6bbb82026-02-09Warnings, Adverse reactionsExact identifier
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
rxcui: 905395
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEA-S Medication Solutionsf16f1d87-f9e6-4555-9baf-26ff17cb1d282025-12-05Warnings, Adverse reactionsExact identifier
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
application number: ANDA205236
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
rxcui: 905199
unii: FD171B778Y

Reported adverse events (FAERS/openFDA)#

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