FDA.reportPublic FDA data

NDC 68071-5285-01 - 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
68071-5285
Requested NDC
68071-5285-01
Package NDCs from labels
68071-5285-1, 68071-5285-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-12-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HYDRALAZINE HYDROCHLORIDE TABLETS, USPNuCare Pharmaceuticals,Inc.2024-12-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5285-1Hydralazine Hydrochloride100 in 1 BOTTLETABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5285HYDRALAZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20241219_a862321d-ebc1-7676-e053-2995a90a5861.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 6 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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.