FDA.reportPublic FDA data

NDC 70518-3659-2 - 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
70518-3659
Requested NDC
70518-3659-2
Package NDCs from labels
70518-3659-0, 70518-3659-2, 70518-3659-1
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
hydrALAZINE Hydrochloride Injection, USPREMEDYREPACK INC.2026-08-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3659-0hydrALAZINE Hydrochloride25 in 1 TRAYINJECTION253
70518-3659-0hydrALAZINE Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION13
70518-3659-1hydrALAZINE Hydrochloride25 in 1 TRAYINJECTION253
70518-3659-2hydrALAZINE Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3659HYDRALAZINE HYDROCHLORIDE INJECTION [REMEDYREPACK INC.]1Current NDC, 4 package rows20240922_dca82025-a4cd-4856-aa19-bdf091bf8973.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 5 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECoupler LLC41c019e3-7b07-5f12-e063-6294a90a53652025-10-22Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Walgreens Ultra LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4533-2061-e063-6394a90a6e732025-10-17WarningsExact identifier
unii: 6DC9Q167V3
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEMedical Purchasing Solutions, LLC3f8fb1fc-ffef-4f94-e063-6294a90a2b822025-09-24Warnings, Adverse reactionsExact identifier
rxcui: 966571
unii: FD171B778Y
Dry eye reliefPOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADERf8da3af5-9172-4023-be82-0fd5bd8916162025-09-12WarningsExact identifier
unii: 6DC9Q167V3
Systane COMPLETEPROPYLENE GLYCOLAlcon Laboratories, Inc.2df0de02-a3e2-471a-9e10-040c3fba75fe2025-08-08WarningsExact identifier
unii: 6DC9Q167V3
Systane BalancePROPYLENE GLYCOLAlcon Laboratories, Inc.c7b1a03a-a5f2-409e-a34a-d6f166671de52025-08-07WarningsExact identifier
unii: 6DC9Q167V3
Systane UltraPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.0537c23a-15f7-be64-1231-a6c93468e9a82025-07-30WarningsExact identifier
unii: 6DC9Q167V3
SystanePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.1d679d0f-cec2-a644-79cd-079607254bb92025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane Ultra Preservative FreePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.751fb85f-6683-4b0a-a650-324d4a74c5de2025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.99b63d62-1cf0-4f28-8760-773917c2538a2025-07-29WarningsExact identifier
unii: 6DC9Q167V3
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEMylan Institutional Inc.493a8b7e-5bb1-4db2-91a7-77ed878641312025-07-22Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
hydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEProPharma Distribution3855c3da-ff25-8301-e063-6294a90a22b32025-07-18Warnings, Adverse reactionsExact identifier
application number: ANDA040388
rxcui: 966571
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEProficient Rx LP024ac6b8-5ce0-4435-9b11-b1806c511d7b2025-07-01Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Isosorbide dinitrate and hydralazine hydrochlorideISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDEIngenus Pharmaceuticals, LLC8f54d5a3-169f-48dd-9250-2c176d2bd9ad2025-06-03Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEHenry Schein, Inc.4d1f55aa-e924-4540-ae9f-bd7362a82f332025-05-20Warnings, Adverse reactionsExact identifier
application number: ANDA040388
rxcui: 966571
unii: FD171B778Y
Bestmade Natural Products BM182 PelletsGRAPHITES, HEPAR SULF, MERC SOL, MURIATIC ACIDBestmade Natural Products3242e013-2952-2b56-e063-6294a90a16932025-04-08WarningsExact identifier
unii: QTT17582CB
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepacka79ddc89-546b-4808-879d-c0f5921416362025-03-31Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack90c18c55-3045-4a10-a2bb-012e4a5e15642025-03-25Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECamber Pharmaceuticals, Inc.5da36930-d3da-4b5c-9e22-2b141bc01a9c2025-03-13Warnings, Adverse reactionsExact identifier
unii: FD171B778Y

Reported adverse events (FAERS/openFDA)#

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