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 4 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
isosorbide dinitrate and hydralazine hydrochlorideHYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATEBryant Ranch Prepack2a6fe05a-fcd4-42d1-bf5d-1d39ac2733632024-07-01Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEGlenmark Pharmaceuticals Inc., USA37ba0233-ed75-498a-a067-6220da5736532024-05-24Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905199
rxcui: 905395
rxcui: 905222
unii: FD171B778Y
isosorbide dinitrate and hydralazine hydrochlorideISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDEi3 Pharmaceuticals, LLCcacf1a7c-0388-09ee-e053-2995a90a10cf2024-05-16Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEModavar Pharmaceuticals LLCa456bc34-0c79-44f4-9119-50028a978f5f2024-05-14Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905395
rxcui: 905222
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECivica, Inc.ffa483a4-de2a-4d42-ad27-afacd37f28e42024-04-28Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
HydrALAZINE hydrochlorideHYDRALAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.3f5f1204-d289-40e9-be84-a29352f64bfb2024-04-10Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst15b0f03b-b5a2-c49d-e063-6394a90a5b152024-04-09Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCc2638ae6-a210-490f-8389-bbed6a3229c52024-04-03Warnings, Adverse reactionsExact identifier
application number: ANDA205236
rxcui: 905225
rxcui: 905395
rxcui: 905222
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack8224aa3d-b1b9-40df-93fd-a91c6a1588982024-02-20Warnings, Adverse reactionsExact identifier
application number: ANDA205236
rxcui: 905225
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepackbc37cf50-b18d-467e-bf67-3270faa8332e2024-02-05Warnings, Adverse reactionsExact identifier
application number: ANDA205236
rxcui: 905222
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepackd5b0165e-9823-470a-8ed0-5c4c8722369d2024-02-05Warnings, Adverse reactionsExact identifier
application number: ANDA205236
rxcui: 905395
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack4d1594dc-376b-44bd-8c0e-5de731dfb7f92024-02-02Warnings, Adverse reactionsExact identifier
application number: ANDA205236
ndc (package): 72162-1535-1
ndc (package): 72162-1535-0
ndc (product): 72162-1535
ndc11 (package): 72162153501
rxcui: 905199
spl id: 87e2972a-b207-4248-a0f7-a2719961751f
spl set id: 4d1594dc-376b-44bd-8c0e-5de731dfb7f9
unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst9949407f-e410-7f47-e053-2995a90a73692024-01-30Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack18dd864f-1e27-4c98-8f21-eaded77a3ed62024-01-11Warnings, Adverse reactionsExact identifier
application number: ANDA205236
rxcui: 905395
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepacke6d4b15e-1407-4783-94e4-9971dea682212024-01-11Warnings, Adverse reactionsExact identifier
application number: ANDA205236
rxcui: 905199
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack36499d4b-bcaf-4b49-aa2a-10c3e34550d02024-01-11Warnings, Adverse reactionsExact identifier
application number: ANDA205236
rxcui: 905225
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack4985994c-23ab-4409-bab6-5a17db767f132024-01-11Warnings, Adverse reactionsExact identifier
application number: ANDA205236
rxcui: 905199
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack162a0c00-4db8-4f8d-9686-be2f8449abd82024-01-11Warnings, Adverse reactionsExact identifier
application number: ANDA205236
rxcui: 905222
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack914d5b62-6f9b-4665-8562-689367c362302023-12-14Warnings, Adverse reactionsExact identifier
application number: ANDA205236
rxcui: 905199
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepackd4509f69-e60e-4440-957b-5c27144803352023-11-27Warnings, Adverse reactionsExact identifier
application number: ANDA205236
rxcui: 905222
unii: FD171B778Y

Reported adverse events (FAERS/openFDA)#

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