NDC 0641-6190-01 - 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
0641-6190
Requested NDC
0641-6190-01
Package NDCs from labels
0641-6190-01, 0641-6190-10
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
0641-6190-01Midazolam10 mL in 1 VIALINJECTION108
0641-6190-10Midazolam10 in 1 CARTONINJECTION108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6190MIDAZOLAM INJECTION [HIKMA PHARMACEUTICALS USA INC.]8Current NDC, Legacy 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
0641-6190-01ML - Milliliter0641-6190584262a2-67e4-4f8c-ae73-73517c84edcc12017-03-06
0641-6190-10ML - Milliliter0641-6190c556ac86-85c1-47ee-b11a-f8658a537bce12017-03-06

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 39 of 53 · 1,044 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.b56ef662-fec2-4d94-e053-2995a90aba2b2024-01-06WarningsExact identifier
unii: 059QF0KO0R
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC037ac04d-f8f3-4bb8-993a-ac8f7683ff832024-01-04Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
MidazolamMIDAZOLAM HYDROCHLORIDEFresenius Kabi USA, LLC1cc9ba6e-fa1b-405e-9de8-720c567b2a732024-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W7TTW573JJ
Leader Eye WashPURIFIED WATERCardinal Health8d3ad11f-1945-f838-e053-2995a90a7aa52023-12-23WarningsExact identifier
unii: 059QF0KO0R
Sinus HPARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, THUJA OCCIDENTALISEnergique, Inc.3cdddbe5-e3d2-4629-a045-868e18183f1d2023-12-19WarningsExact identifier
unii: 451W47IQ8X
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.28488c7b-cf6a-4a03-916f-cc66b3afdc572023-12-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Altachlore Sodium Chloride HypertonicitySODIUM CHLORIDEAltaire Pharmaceuticals Inc.dc0d94d8-4475-4956-8ded-bdb9496074e42023-12-09WarningsExact identifier
unii: 451W47IQ8X
MidazolamMIDAZOLAM HYDROCHLORIDESOMERSET THERAPEUTICS, LLC74666098-1ca8-4c06-8fc4-5de870b1b5142023-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1666798
unii: W7TTW573JJ
MidazolamMIDAZOLAM HYDROCHLORIDESOMERSET THERAPEUTICS, LLC06e4f754-72df-4eb4-aaed-b538524f52772023-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311702
unii: W7TTW573JJ
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R
terrasil Eczema and Psoriasis Severe OutbreakGRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIGAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions4d7128fb-57f1-4d0d-a83a-daef40928ecd2023-11-30WarningsExact identifier
unii: 451W47IQ8X
terragen HG Formula Maximum StrengthGRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIGAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionse632c831-e25d-4d04-ba72-2327d25713b12023-11-30WarningsExact identifier
unii: 451W47IQ8X
Femstat CECHINACEA (ANGUSTIFOLIA), FUCUS VESICULOSUS, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, KREOSOTUM, NATRUM MURIATICUM, CANDIDA ALBICANS, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), SEPIAEnergique, Inc.420119ca-f2bf-40e3-9e40-00498724c2282023-11-30WarningsExact identifier
unii: 451W47IQ8X
CVS Maximum Strength LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDECVS Pharmacy Inc.e6aff579-affb-41bb-8e36-53ea484cb0c52023-11-26WarningsExact identifier
unii: LKG8494WBH
EndoparGLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, OOPHORINUM (SUIS), ORCHITINUM (BOVINE), PINEAL GLAND, THYROIDINUM, ARSENICUM ALBUM, BARYTA CARBONICA, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PULSATILLA (PRATENSIS)Energique, Inc.06375c3e-cc05-4450-9117-1d3dc72636eb2023-11-21WarningsExact identifier
unii: 451W47IQ8X
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643994f-4e13-4572-e053-2991aa0a5b782023-11-14Exact identifier
unii: QTT17582CB
Muriaticum acidumHYDROCHLORIC ACIDBoiron6907bbfe-caa5-2ce4-e053-2991aa0ade8d2023-11-14Exact identifier
unii: QTT17582CB
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643c518-13b2-658a-e053-2a91aa0ac5ed2023-11-14Exact identifier
unii: QTT17582CB
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643e30e-1f47-09f1-e053-2991aa0ac2de2023-11-14Exact identifier
unii: QTT17582CB
Natrum muriaticumSODIUM CHLORIDEBoiron8646d7ea-cf5e-607d-e053-2a91aa0aeca12023-11-14Exact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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