FDA.reportPublic FDA data

NDC 72572-265-01 - 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
72572-265
Requested NDC
72572-265-01
Package NDCs from labels
72572-265-01, 72572-265-25
Manufacturer
Civica, Inc. | American Regent, Inc.
Effective date
2024-04-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HydrALAZINE Hydrochloride Injection, USPCivica, Inc. | American Regent, Inc.2024-04-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72572-265-01Hydralazine Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION14
72572-265-25Hydralazine Hydrochloride25 in 1 TRAYINJECTION, SOLUTION254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-265HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [CIVICA, INC.]4Current NDC, Legacy NDC, 2 package rows20240429_ffa483a4-de2a-4d42-ad27-afacd37f28e4.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 12 of 19 · 379 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SootheGLYCERIN AND PROPYLENE GLYCOLBausch & Lomb Incorporatedfef002ea-c4bd-4486-a42e-1bbd9d73d28d2024-09-20WarningsExact identifier
unii: 6DC9Q167V3
Leader Preservative-Free Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Health2a2aa620-ca63-4698-88fd-fc263b8fa0d12024-09-07WarningsExact identifier
unii: 6DC9Q167V3
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEMacleods Pharmaceuticals Limitedf9f56326-6d72-47d3-89ac-3625b8a6d7132024-09-06Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsf07abdec-6d94-45b6-be1b-10a898ea28c22024-08-12Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEA-S Medication Solutions8ade1ffe-3738-4aa1-b9c7-59f7290600b92024-08-07Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEA-S Medication Solutionsa8194ac4-02d5-4aa1-b4e4-a3759f6f64b52024-08-07Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.3b61d1b0-c699-67a8-e054-00144ff88e882024-07-16Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.4b7d3378-86f8-0a5f-e054-00144ff8d46c2024-07-15Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
isosorbide dinitrate and hydralazine hydrochlorideHYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATEBryant Ranch Prepack2a6fe05a-fcd4-42d1-bf5d-1d39ac2733632024-07-01Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
isosorbide dinitrate and hydralazine hydrochlorideISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDEi3 Pharmaceuticals, LLCcacf1a7c-0388-09ee-e053-2995a90a10cf2024-05-16Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEModavar Pharmaceuticals LLCa456bc34-0c79-44f4-9119-50028a978f5f2024-05-14Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
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
application number: ANDA040136
ndc (package): 72572-265-25
ndc (package): 72572-265-01
ndc (product): 72572-265
ndc11 (package): 72572026501
rxcui: 966571
spl id: c25506f2-689e-4053-b858-8424e6724ed6
spl set id: ffa483a4-de2a-4d42-ad27-afacd37f28e4
unii: FD171B778Y

Reported adverse events (FAERS/openFDA)#

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