FDA.reportPublic FDA data

NDC 68475-514-01 - 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
68475-514
Requested NDC
68475-514-01
Package NDCs from labels
68475-514-01, 68475-514-02
Manufacturer
Navinta LLC
Effective date
2026-04-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydralazine Hydrochloride - Navinta LLCNavinta LLC2026-04-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68475-514-01Hydralazine Hydrochloride1 mL in 1 VIALINJECTION12
68475-514-02Hydralazine Hydrochloride25 in 1 PACKAGEINJECTION252

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 19 of 19 · 371 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEAmerican Regent, Inc.17210abc-58f6-442e-8ff2-7971333c82f62019-05-06Warnings, Adverse reactionsExact identifier
rxcui: 966571
unii: FD171B778Y
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEAscend Laboratories, LLCe7bfec3d-5222-4a26-8f99-6c2a28e14aa62017-12-28Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCbfbd5960-ae6b-46f5-adfa-e330d7a21dfa2017-12-21Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
HydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC921c8693-84c2-4313-a2a6-ab3be637d5542016-07-14Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd9892176-d4a6-4edb-92b9-5f56243f3d222016-06-13Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.ddbbdb09-3202-42d7-bbb0-08331dde2f542016-02-29Warnings, Adverse reactionsExact identifier
unii: FD171B778Y

Reported adverse events (FAERS/openFDA)#

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