FDA.reportPublic FDA data

NDC 0641-6231-01 - 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
0641-6231
Requested NDC
0641-6231-01
Package NDCs from labels
0641-6231-01, 0641-6231-25
Manufacturer
Henry Schein, Inc.
Effective date
2025-02-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydralazine HydrochlorideHenry Schein, Inc.2025-02-10HUMAN PRESCRIPTION DRUG LABEL
HydrALAZINE Hydrochloride Injection, USP Preservative-Free Rx onlyHikma Pharmaceuticals USA Inc.2024-04-10HUMAN PRESCRIPTION DRUG LABEL
HydrALAZINE hydrochloride - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-05-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6231-01HydrALAZINE hydrochloride20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION202
0641-6231-25HydrALAZINE hydrochloride25 in 1 CARTONINJECTION, SOLUTION252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6231HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]2Current NDC, Legacy NDC, 2 package rows20240411_3f5f1204-d289-40e9-be84-a29352f64bfb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6231-01ML - Milliliter0641-62319926f261-4f08-4c40-881f-705a84720c4d12021-05-05
0641-6231-25ML - Milliliter0641-6231b0027ea1-addf-4d1b-86ed-fb39abf4093c12021-05-05

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 19 · 377 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Leader Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Healthd7f011a2-05ba-47c3-9519-d31602e105c72026-03-12WarningsExact identifier
unii: 6DC9Q167V3
Leader Restorative Formula Lubricant Eye DropsPROPYLENE GLYCOLCardinal Health87fef7e4-e5a8-4aad-94d2-f80f34826d972026-03-12WarningsExact identifier
unii: 6DC9Q167V3
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDESafecor Health, LLC66c5eaa4-a51a-464b-98ad-f094f32876dd2026-03-11Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Skin Irritations and Itch ReliefAGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.King Bio Inc.d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd2026-03-10WarningsExact identifier
unii: QTT17582CB
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.f3c806a4-b971-421c-bcb9-9979c6d7aaec2026-02-27Warnings, Adverse reactionsExact identifier
rxcui: 966571
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECoupler LLC4aa1b3e8-9389-fe2c-e063-6294a90a7fb92026-02-12Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.89afc8ef-27c4-489a-81de-3f8f65f6bbb82026-02-09Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Droptics Performance Eye DropsNAPHAZOLINE HYDROCHLORIDE, PROPYLENE GLYCOLDroptics LLC20fd6822-a7fd-4593-92bb-0a07260893e22026-02-09WarningsExact identifier
unii: 6DC9Q167V3
HydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEStrides Pharma Science Limitedb3d1786d-c3ff-42f1-a09f-37a9c9021e5a2026-02-02Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Endotoxin Terrain Drops 2143ENDOTOXIN TERRAIN DROPSProfessional Complementary Health Formulas58842566-005a-48b5-973d-20cde2fbd7012026-01-08WarningsExact identifier
unii: QTT17582CB
Lubricant Eye Drops SolutionPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAvPAKf5743b38-e3d2-a065-e053-2995a90a4b9a2026-01-08WarningsExact identifier
unii: 6DC9Q167V3
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Abdominal Pain Drops 2051ABDOMINAL PAIN DROPSProfessional Complementary Health Formulasf1b1dde6-bb37-4774-a58c-b4f648f9c2b52026-01-08WarningsExact identifier
unii: QTT17582CB
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.e9450e82-329f-4fd8-a0b3-3e8e227159652026-01-07Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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