FDA.reportPublic FDA data

NDC 0641-6281-01 - Midazolam

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
0641-6281
Requested NDC
0641-6281-01
Package NDCs from labels
0641-6281-01, 0641-6281-25
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2024-12-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Midazolam Injection, USP - NOVAPLUS®Hikma Pharmaceuticals USA Inc.2024-12-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6281-01Midazolam2 mL in 1 VIALINJECTION28
0641-6281-25Midazolam25 in 1 CARTONINJECTION258

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6281MIDAZOLAM INJECTION [HIKMA PHARMACEUTICALS USA INC.]8Current NDC, 2 package rows20241219_f8bb3427-c887-47b6-8042-8a21dc161c79.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6281-01ML - Milliliter0641-628113ea4f44-0edd-4ce4-a14b-5e32347f8a2e12025-01-14
0641-6281-25ML - Milliliter0641-628153894012-6f68-4b57-bbc8-ced9ce13df9612025-01-14

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 29 of 56 · 1,117 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Midazolam In Sodium ChlorideMIDAZOLAM IN SODIUM CHLORIDEFRESENIUS KABI USA, LLCc8f51630-e776-4bc6-ba4d-b714e8c3b8f22025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W7TTW573JJ
Sodium Chloride Normal SaltSODIUM CHLORIDECitragen Pharmaceuticals Incaae783b2-18fe-69ca-e053-2a95a90a08002025-01-30WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride Normal SaltSODIUM CHLORIDECitragen Pharmaceuticals Inc82c29f1d-a018-7483-e053-2a91aa0a8f7e2025-01-30WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM62AMMONIUM BENZOICUM, AURUM MUR, CALC ARS, CARDUUS MAR, CROTALUS HORRIDUS, MURIATIC ACID, NUX VOM, PHOSPHORUS, VIPERABestmade Natural Products2ce99cb7-fe9e-5da2-e063-6294a90afc4e2025-01-30WarningsExact identifier
unii: QTT17582CB
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM68PHOSPHORUS, ARG NIT, GELSEMIUM, NAT MUR, KALI BROM, BARYTA CARBBestmade Natural Products2cec9c90-2e61-f005-e063-6294a90a87532025-01-30WarningsExact identifier
unii: 451W47IQ8X
RecovatoneGLYCYRRHIZA GLABRA, KALI MURIATICUM, KALI PHOSPHORICUM, IODIUM, ZINCUM GLUCONICUM, PHOSPHORUS, ASCORBICUM ACIDUM, CALCIUM GLUCONATE, L-ARGININE, L-CARNITINE, L-ORNITHINE, MAGNESIA MURIATICA, MAGNESIUM GLUCONICUM DIHYDRICUM, MANGANESE GLUCONATE, NATRUM MURIATICUM, COBALT GLUCONATE, COPPER GLUCONATE, CREATINE, L-GLUTAMINE, L-LEUCINE, L-VALINE, POTASSIUM GLUCONATE, SELENIUM DIOXIDE, ADRENALINUM, BORON, CALCAREA PHOSPHORICA, FERRUM SULPHURICUM, MOLYBDENUM, NICCOLUM METALLICUM, SELENIUM METALLICUM,Energique, Inc.8ca76872-a187-4fd8-8daf-9ee351bdf3462025-01-28WarningsExact identifier
unii: 451W47IQ8X
WHP HeadacheATROPA BELLADONNA - BRYONIA ALBA ROOT - SODIUM CHLORIDE - STRYCHNOS NUX-VOMICA SEEDWashington Homeopathic Products06d25564-4c7e-0b3a-e063-6294a90a38bf2025-01-28WarningsExact identifier
unii: 451W47IQ8X
Fever-InfectionCHAMOMILLA, ECHINACEA HYDRASTIS CANADENSIS, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAMPHORA, CINA, CINCHONA OFFICINALIS, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, IGNATIA AMARA, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, SALIX NIGRA, VERATRUM VIRIDE, INFLUENZINUMNewton Laboratories, Inc.9d762268-8c30-8a86-e053-2a95a90a419c2025-01-27WarningsExact identifier
unii: 451W47IQ8X
Histastat PollenBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SABADILLA, SINAPIS NIGRA, SOLIDAGO VIRGAUREA, SULPHUR, WYETHIA HELENIOIDESEnergique, Inc.5a94659f-b62a-41d8-81c0-87a68c02606d2025-01-27WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM59CALC CARB, DULCAMARA, HEPAR SULPH, LYCOPODIUM, NAT MUR, SULPHUR, THUJA OCCBestmade Natural Products2c763956-a1de-c8df-e063-6294a90a5c812025-01-24WarningsExact identifier
unii: 451W47IQ8X
Equate Sterile Saline MistSODIUM CHLORIDEWALMART INC.275ada29-8904-fe1e-e063-6394a90abe592025-01-24WarningsExact identifier
unii: 451W47IQ8X
Glucose and Sodium ChlorideDEXTROSE ANHYDROUS AND SODIUM CHLORIDEBaxter Healthcare Corporation1ba918d0-13d0-48bc-8742-658fc0eb47b62025-01-24Exact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation93aeac13-41de-4452-9f38-d6b4f38ada302025-01-24Exact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM33ACID FOLICD10, ACID PHOSD4, ARSENIC ALBD4, AVENA SATD3, BETA VULGD5, CHINA OFFD12, FERR METD5, NATRUM MURD5Bestmade Natural Productsef2beaff-5c94-de60-e053-2995a90ad7962025-01-23WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Nat Mur (Lactose-Free)NATRUM MURIATICUMBestmade Natural Products2c4b8827-e724-858a-e063-6394a90a3b4e2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio1CALC PHOS, FERR PHOS, KALI PHOS, NAT MURBestmade Natural Productse9fb280b-2f79-f268-e053-2995a90a732c2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio2KALI PHOS, MAG PHOS, NAT MUR, NAT SULFBestmade Natural Productse9fc4f2f-a699-163f-e053-2995a90ab1fe2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio4CALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Productsea224687-106e-3821-e053-2995a90aa69c2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio5FERR PHOS, KALI MUR, NAT MUR, KALI SULPHBestmade Natural Productsea22e5e7-491a-91ac-e053-2a95a90a44142025-01-22WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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