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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0641-6281-01	Midazolam	2 mL in 1 VIAL	INJECTION	2		8
0641-6281-25	Midazolam	25 in 1 CARTON	INJECTION	25		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6281	MIDAZOLAM INJECTION [HIKMA PHARMACEUTICALS USA INC.]	8	Current NDC, 2 package rows	20241219_f8bb3427-c887-47b6-8042-8a21dc161c79.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6281-01	ML - Milliliter	0641-6281	13ea4f44-0edd-4ce4-a14b-5e32347f8a2e	1	2025-01-14
0641-6281-25	ML - Milliliter	0641-6281	53894012-6f68-4b57-bbc8-ced9ce13df96	1	2025-01-14

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 42 of 56 · 1,117 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
F19 STRNG-MND	ANACARDIUM ORIENTALE, ARNICA MONTANA, AURUM METALLICUM, CASTANEA SATIVA, CITRUS SINENSIS, CRATAEGUS MONOGYNA, CYTISUS SCOPARIUS, DANDELION, FAGUS SYLVATICA, FUCHSIA, GORSE, HYDRASTIS CANADENSIS, IGNATIA AMARA, IRON, KALI PHOSPHORICUM, MALUS SYLVESTRIS, NATRUM MURIATICUM, PAEONIA CALIFORNICA, POMEGRANATE, PRUNELLA VULGARIS, ROSA CALIFORNICA, SINAPIS ARVENSIS, YARROW, YERBA SANTA	Apex Energetics Inc.	bec4e5d7-d968-175b-e053-2a95a90a4e0a	2024-01-08	Warnings	Exact identifier unii: 451W47IQ8X
F22 SOMATICA	AGRIMONY, CALOCHORTUS TOLMIEI, CIMICIFUGA RACEMOSA, CLEMATIS VITALBA, DANDELION, DIPLACUS AURANTIACUS, ECHINACEA ANGUSTIFOLIA, EHRENDORFERIA CHRYSANTHA, FUCHSIA, HYDRASTIS CANADENSIS, KALI PHOSPHORICUM, LARIX DECIDUA, LATHYRUS ODORATUS, LONICERA CAPRIFOLIUM, NATRUM MURIATICUM, ROSA CALIFORNICA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR, YARROW, YERBA SANTA	Apex Energetics Inc.	bed99bed-3902-5278-e053-2a95a90aeab6	2024-01-08	Warnings	Exact identifier unii: 451W47IQ8X
F27 MVON	AGRIMONY, ARNICA MONTANA, ARSENICUM ALBUM, ARTEMISIA TRIDENTATA, ASPEN, CHAMOMILE, CHICORY, DICENTRA FORMOSA, EHRENDORFERIA CHRYSANTHA, EUCALYPTUS GLOBULUS, HARDY FUCHSIA, HORSE CHESTNUT, IGNATIA AMARA, JUGLANS REGIA, LACHESIS MUTUS, LARIX DECIDUA, MIMULUS GUTTATUS, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, PALLADIUM, PERFOLIATE HONEYSUCKLE, PETUNIA AXILLARIS, PULSATILLA VULGARIS, PYRENEES STAR OF BETHLEHEM, SCOTCH BROOM, TRILLIUM CHLOROPETALUM, YELLOW JASMINE, YERBA SANTA, ZINNIA ELEGANS	Apex Energetics Inc.	bca69508-0934-ecfc-e053-2995a90a0ce3	2024-01-08	Warnings	Exact identifier unii: 451W47IQ8X
F26 PRSVR	ALLIUM CEPA WHOLE, APIS MELLIFICA, AURUM METALLICUM, BORAGE, BROMUS RAMOSUS, CALIFORNIA WILDROSE WHOLE, ENGLISH ELM ING TWIG, ENGLISH HAWTHRON, ENGLISH OAK, EUROPEAN HORNBEAM, EUROPEAN OLIVE, GENTIANELLA AMARELLA, GORSE, LARIX DECIDUA, LUFFA OPERCULATA, MERCURIUS SOLUBILIS, MULLEIN, NATRUM MURIATICUM, PENSTEMON DAVIDSONII WHOLE, PLATINUM METALLICUM, PULSATILLA VULGARIS, PURPLE LOOSESTRIFE WHOLE, ROSA CHINENSIS, SCOTCH BROOM, SEPIA, WILD MUSTARD, YERBA SANTA, ZINCUM METALLICUM	Apex Energetics Inc.	beaef254-bf57-df92-e053-2995a90abd65	2024-01-08	Warnings	Exact identifier unii: 451W47IQ8X
G05 OXI-MET	ADENOSINE TRIPHOSPHATE, IGNATIA AMARA, KALI PHOSPHORICUM, NATRUM MURIATICUM, NUX VOMICA, SULPHUR	Apex Energetics Inc.	beb18213-911a-38d4-e053-2a95a90ac17c	2024-01-08	Warnings	Exact identifier unii: 451W47IQ8X
LIVER PLUS Formula	ADENOSINE TRIPHOSPHATE, IGNATIA AMARA, KALI PHOSPHORICUM, NATRUM MURIATICUM, NUX VOMICA, SULPHUR	Apex Energetics Inc.	d8c7b349-8718-d8ed-e053-2995a90ae988	2024-01-08	Warnings	Exact identifier unii: 451W47IQ8X
Fendall 2000 Pure Flow	PURIFIED WATER	Honeywell Safety Products USA, Inc.	b56ef662-fec2-4d94-e053-2995a90aba2b	2024-01-06	Warnings	Exact identifier unii: 059QF0KO0R
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	037ac04d-f8f3-4bb8-993a-ac8f7683ff83	2024-01-04	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Midazolam	MIDAZOLAM HYDROCHLORIDE	Fresenius Kabi USA, LLC	1cc9ba6e-fa1b-405e-9de8-720c567b2a73	2024-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: W7TTW573JJ
Leader Eye Wash	PURIFIED WATER	Cardinal Health	8d3ad11f-1945-f838-e053-2995a90a7aa5	2023-12-23	Warnings	Exact identifier unii: 059QF0KO0R
Sinus HP	ARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, THUJA OCCIDENTALIS	Energique, Inc.	3cdddbe5-e3d2-4629-a045-868e18183f1d	2023-12-19	Warnings	Exact identifier unii: 451W47IQ8X
BSS	BALANCED SALT SOLUTION	Alcon Laboratories, Inc.	28488c7b-cf6a-4a03-916f-cc66b3afdc57	2023-12-14	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Midazolam	MIDAZOLAM HYDROCHLORIDE	Steriscience Specialties Private Limited	473fba4b-8754-4b1d-bba9-d9c8f6d818e0	2023-12-13	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 311702 unii: W7TTW573JJ
Altachlore Sodium Chloride Hypertonicity	SODIUM CHLORIDE	Altaire Pharmaceuticals Inc.	dc0d94d8-4475-4956-8ded-bdb9496074e4	2023-12-09	Warnings	Exact identifier unii: 451W47IQ8X
Midazolam	MIDAZOLAM HYDROCHLORIDE	SOMERSET THERAPEUTICS, LLC	74666098-1ca8-4c06-8fc4-5de870b1b514	2023-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1666798 unii: W7TTW573JJ
Midazolam	MIDAZOLAM HYDROCHLORIDE	SOMERSET THERAPEUTICS, LLC	06e4f754-72df-4eb4-aaed-b538524f5277	2023-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 311702 unii: W7TTW573JJ
Eye Wash	WATER	Jiangxi Zhenmei Biological Technology Co.,Ltd	c68795b8-bf68-0d01-e053-2a95a90abebb	2023-12-04	Warnings	Exact identifier unii: 059QF0KO0R
terrasil Eczema and Psoriasis Severe Outbreak	GRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIG	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	4d7128fb-57f1-4d0d-a83a-daef40928ecd	2023-11-30	Warnings	Exact identifier unii: 451W47IQ8X
terragen HG Formula Maximum Strength	GRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIG	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	e632c831-e25d-4d04-ba72-2327d25713b1	2023-11-30	Warnings	Exact identifier unii: 451W47IQ8X
Femstat C	ECHINACEA (ANGUSTIFOLIA), FUCUS VESICULOSUS, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, KREOSOTUM, NATRUM MURIATICUM, CANDIDA ALBICANS, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), SEPIA	Energique, Inc.	420119ca-f2bf-40e3-9e40-00498724c228	2023-11-30	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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