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 50 of 56 · 1,117 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kids Cold and Cough Nighttime Grape FlavorONION, CHAMOMILE, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS TOP, SULFURHyland's Consumer Health Inc.e676dbb7-212f-47e3-e053-2995a90af4e12022-08-17WarningsExact identifier
unii: 451W47IQ8X
Kids Cold and Cough Daytime Grape FlavorONION, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS WHOLE, SULFURHyland's Consumer Health Inc.e65f14cb-5a8e-0ad5-e053-2a95a90a6f5d2022-08-16WarningsExact identifier
unii: 451W47IQ8X
Sterile Saline Kids Mist PediaMedsSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.e5c5b580-1d9f-3081-e053-2995a90a80312022-08-08WarningsExact identifier
unii: 451W47IQ8X
Sterile Saline Kids Mist SinuCleanse BreatheSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.e5c5c313-046f-b0a7-e053-2a95a90a2a072022-08-08WarningsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporation123bd10a-90c7-499e-97f6-acf7e0f0fb4e2022-07-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLCfad9615f-7004-415d-9f69-ee9ff95f00672022-07-12WarningsExact identifier
unii: 451W47IQ8X
BHI ConstipationDIOSCOREA VILLOSA TUBER, SODIUM CHLORIDE, AND STRYCHNOS NUX-VOMICA SEEDMediNatura Inc0365b75b-fee4-4c1d-89ab-c692bdd73f752022-07-07WarningsExact identifier
unii: 451W47IQ8X
Natrium Muriaticum 6XSODIUM CHLORIDESeroyal USA0ebf18de-12fe-0bc4-e054-00144ff88e882022-07-07WarningsExact identifier
unii: 451W47IQ8X
ErogetoneARALIA QUINQUEFOLIA, BERBERIS VULGARIS, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIAEnergique, Inc.1e872ecd-e7a5-463d-9832-47b7046096db2022-06-28WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Cardioplegic SolutionPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDEFresenius Kabi, USA, LLCeb360dc4-88d6-4b28-9b61-bc359e16bd222022-05-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: 7FLD91C86K
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: 7FLD91C86K
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.24a08a93-df23-474b-873e-c59ec8855f9f2022-03-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Wild Horse 777 Moisturizing NasalSODIUM CHLORIDEWild Horse 777, Inc.b0b4dadd-11fa-3dbb-e053-2995a90a20972022-03-14WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.cc14fafd-3dcd-4fc8-bdbd-6f355c3757682022-02-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC8b44bfd3-70a4-4b47-bc7b-590f63b8cc752022-02-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ACNE HPCARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINCNatural Creations, Inc.b2368ab6-e233-4473-99fa-86e1fbc2a8792022-02-14WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCf62481fd-fcdb-4be6-ac13-29c590e925c32022-02-10Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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