FDA.reportPublic FDA data

NDC 0641-6260-01 - Naloxone 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
0641-6260
Requested NDC
0641-6260-01
Package NDCs from labels
0641-6260-01, 0641-6260-25
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2024-04-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Naloxone Hydrochloride Injection, USPHikma Pharmaceuticals USA Inc.2024-04-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6260-01Naloxone Hydrochloride1 mL in 1 VIALINJECTION12
0641-6260-25Naloxone Hydrochloride25 in 1 CARTONINJECTION252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6260NALOXONE HYDROCHLORIDE (NALXONE HYDROCHLORIDE) INJECTION [HIKMA PHARMACEUTICALS USA INC.]2Current NDC, Legacy NDC, 2 package rows20240411_1bef59b9-7d51-4f19-a054-44b8eb6c6398.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 40 of 58 · 1,154 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEWalgreen Co.3829826b-e48f-4e26-869f-6b9e4ee0a8402024-04-24WarningsExact identifier
unii: F850569PQR
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLCc1e52670-c85e-4f19-a2e9-bf9abd7c37272024-04-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R
DermaparEPIDERMIS (SUIS), ARSENICUM ALBUM, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PETROLEUM, RHUS TOX, SULPHUR, CAUSTICUMEnergique, Inc.f79fe29b-341e-4bee-9665-1805a7157d1a2024-04-22WarningsExact identifier
unii: 451W47IQ8X
Naloxone HydrochlorideNALOXONEAmneal Pharmaceuticals NY LLC8779a073-dc6e-410a-9959-fd370f0079f92024-04-19WarningsExact identifier
unii: F850569PQR
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
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMylan Institutional LLC7faaedb3-227b-408d-b772-6b326638b00e2024-04-12Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEPar Health USA, LLC3ae08e26-223b-4971-b2f1-f1e183a3f9302024-04-11Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEHikma Pharmaceuticals USA Inc.e5ee8caa-b6ca-45ba-98fb-8305e62821412024-04-10Adverse reactionsExact identifier
unii: 451W47IQ8X
Naloxone HydrochlorideNALXONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.1bef59b9-7d51-4f19-a054-44b8eb6c63982024-04-10Warnings, Adverse reactionsExact identifier
application number: ANDA070299
ndc (package): 0641-6260-01
ndc (package): 0641-6260-25
ndc (product): 0641-6260
ndc11 (package): 00641626001
rxcui: 1659929
spl id: 531da15c-9a2c-4121-9aa5-85b079d3908b
spl set id: 1bef59b9-7d51-4f19-a054-44b8eb6c6398
unii: F850569PQR
Sterile WaterWATERB. Braun Medical Inc.8fc8d87a-3951-4ac5-97df-c161ffc904752024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hers PlusCALENDULA OFFICINALIS, SAMBUCUS NIGRA, ALLIUM SATIVUM, CLEMATIS ERECTA, DULCAMARA, SARSAPARILLA (SMILAX REGELII), GRAPHITES, PETROLEUM, ARSENICUM ALBUM, CROTON TIGLIUM, MERCURIUS SULPHURATUS RUBER, NATRUM MURIATICUM, NITRICUM ACIDUM, RHUS TOX, SEPIA, THUJA OCCIDENTALISDeseret Biologicals,Inc.e4636b80-f6c8-459c-8d0e-ff7801358b102024-04-09WarningsExact identifier
unii: 451W47IQ8X
Dextrose And Sodium ChlorideDEXTROSE AND SODIUM CHLORIDEB. Braun Medical Inc.8e6569ce-9714-497f-a94b-c6975c1d76f62024-04-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SINU HCPLANTAGO MAJOR, PULSATILLA (PRATENSIS), LUFFA OPERCULATA, MERCURIUS IODATUS RUBER, MUCOSA NASALIS SUIS, EUPHORBIUM OFFICINARUM, ARGENTUM NITRICUM, HEPAR SULPHURIS CALCAREUM, CALCAREA CARBONICA, NATRUM MURIATICUM, SINUSITISINUMDeseret Biologicals, Inc.8b63e066-dd1b-4aee-a17b-4edc6b71a1cc2024-04-02WarningsExact identifier
unii: 451W47IQ8X
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R
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
CVS Health Sterile Saline MistSODIUM CHLORIDECVS Pharmacy14931004-1efb-e331-e063-6294a90ad66e2024-03-26WarningsExact identifier
unii: 451W47IQ8X
Aqua marinaSODIUM CHLORIDEBoiron14945760-30b5-27d3-e063-6394a90a8a322024-03-26Exact identifier
unii: 451W47IQ8X
Headache HPBELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUMEnergique, Inc.5dca8670-c931-47e3-af89-b5f09f5f4e022024-03-26WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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