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 8 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fatigue Stat CMECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, ARANEA DIADEMA, IPECACUANHA, IRIDIUM METALLICUM, LACHESIS MUTUS, MURIATICUM ACIDUM, RHUS TOX, CYTOMEGALOVIRUS NOSODEEnergique, Incaebdb08b-48aa-46f2-930f-f98f5b06a6042024-05-08WarningsExact identifier
unii: QTT17582CB
EnviroclenzBERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.92816bbe-96d6-45fc-9929-d3e6df394a332024-05-02WarningsExact identifier
unii: 6DC9Q167V3
REFL HSADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREAS SUIS, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)Deseret Biologicals, Inc.83249aee-f58b-442d-9187-6de0cf070e4d2024-04-29WarningsExact identifier
unii: QTT17582CB
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECivica, Inc.ffa483a4-de2a-4d42-ad27-afacd37f28e42024-04-28Warnings, Adverse reactionsExact identifier
rxcui: 966571
unii: FD171B778Y
EVTOXCOCHLEARIA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODEBioActive Nutritional, Inc.4b518e10-9ce0-492b-92be-6025d8d7c3c62024-04-19WarningsExact identifier
unii: QTT17582CB
HydrALAZINE hydrochlorideHYDRALAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.3f5f1204-d289-40e9-be84-a29352f64bfb2024-04-10Warnings, Adverse reactionsExact identifier
rxcui: 966571
unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst15b0f03b-b5a2-c49d-e063-6394a90a5b152024-04-09Warnings, Adverse reactionsExact identifier
rxcui: 966571
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCc2638ae6-a210-490f-8389-bbed6a3229c52024-04-03Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Oral HealthANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, BORAX, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CHAMOMILLA, CINCHONA OFFICINALIS, DISCUS INTERVERTEBRALIS SUIS, STREPTOCOCCUS DYSGALACTIAE DNA, STREPTOCOCCUS MUTANS DNA, STREPTOCOCCUS PNEUMONIAE DNA, ECHINACEA PURPUREA, IGNATIA AMARA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NUX MOSCHATA, ORAL MUCOSA (SUIS), OXYGENIUM, SAMBUCUS NIGRA, SEPIA, STAPHYLOCOCCUS AUREUS,Deseret Biologicals, Inc.6f66ff40-6e0e-4a35-963c-965c65df76eb2024-04-01WarningsExact identifier
unii: QTT17582CB
EnvirotoxTRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM.BioActive Nutritional, Inc.2b5cfdba-cf4d-4eb0-8c60-20eac69226632024-03-26WarningsExact identifier
unii: 6DC9Q167V3
HabitCHAMOMILLA, NATRUM PHOSPHORICUM, VALERIANA OFFICINALIS, PASSIFLORA INCARNATA, ARGENTUM NITRICUM, CALADIUM SEGUINUM, CINCHONA OFFICINALIS, MURIATICUM ACIDUM, SACCHARUM OFFICINALE, AVENA SATIVA, TABACUM, CEREBRUM SUIS, SEROTONIN (HYDROCHLORIDE), ARGEMONE MEXICANA, AGARICUS MUSCARIUS, ARSENICUM ALBUM, AURUM METALLICUM, IPECACUANHA, SEPIA, HYPOTHALAMUS (BOVINE), VIPERA BERUSDeseret Biologicals, Inc.3d00a305-e15d-4419-97bd-332421d4a1b02024-03-15WarningsExact identifier
unii: QTT17582CB
Oral HealthBORAX, BRYONIA (ALBA), ECHINACEA PURPUREA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MURIATICUM ACIDUM, DISCUS INTERVERTEBRALIS SUIS, ORAL MUCOSA (SUIS), ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, CHAMOMILLA, CINCHONA OFFICINALIS, NUX MOSCHATA, SAMBUCUS NIGRA, SEPIA, MERCURIUS SOLUBILIS, CALCAREA PHOSPHORICA, IGNATIA AMARA, OXYGENIUM, CANDIDA ALBICANS, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS MUTANSDeseret Biologicals, Inc.81ffb30f-5255-4e16-ba9d-b0de909aa5572024-03-05WarningsExact identifier
unii: QTT17582CB
EPST PLUSCARDUUS MARIANUS, CISTUS CANADENSIS, DULCAMARA, GALIUM APARINE, MAGNESIA MURIATICA, NATRUM SULPHURICUM, VISCUM ALBUM, MURIATICUM ACIDUM, FOLLICULINUM, AQUA MARINA, AILANTHUS GLANDULOSUS, BARYTA MURIATICA, CADMIUM METALLICUM, CEANOTHUS AMERICANUS, COCCULUS INDICUS, IRIDIUM METALLICUM, THUJA OCCIDENTALIS, CINCHONA OFFICINALIS, CALCAREA CARBONICA, CROTALUS CASCAVELLADeseret Biologicals, Inc.c2bb50a8-e4f9-4af4-aefc-53c9c3cfcc252024-02-27WarningsExact identifier
unii: QTT17582CB
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack8224aa3d-b1b9-40df-93fd-a91c6a1588982024-02-20Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepackbc37cf50-b18d-467e-bf67-3270faa8332e2024-02-05Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepackd5b0165e-9823-470a-8ed0-5c4c8722369d2024-02-05Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack4d1594dc-376b-44bd-8c0e-5de731dfb7f92024-02-02Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst9949407f-e410-7f47-e053-2995a90a73692024-01-30Warnings, Adverse reactionsExact identifier
application number: ANDA040388
rxcui: 966571
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepack18dd864f-1e27-4c98-8f21-eaded77a3ed62024-01-11Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepacke6d4b15e-1407-4783-94e4-9971dea682212024-01-11Warnings, Adverse reactionsExact identifier
unii: FD171B778Y

Reported adverse events (FAERS/openFDA)#

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