NDC 0641-6063-01 - 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: 0641-6063
Requested NDC: 0641-6063-01
Package NDCs from labels: 0641-6063-01, 0641-6063-10, 0641-6063-25
Manufacturer: Hikma Pharmaceuticals USA Inc.
Effective date: 2024-04-09
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	Hikma Pharmaceuticals USA Inc.	2024-04-09	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0641-6063-01	Midazolam	2 mL in 1 VIAL	INJECTION	2	8
0641-6063-10	Midazolam	10 in 1 CARTON	INJECTION	10	8
0641-6063-25	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
0641-6063	MIDAZOLAM INJECTION [HIKMA PHARMACEUTICALS USA INC.]	8	Current NDC, Legacy NDC, 3 package rows	20240410_575d8bf0-7af7-427c-a231-966e2a5e070d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6063-01	ML - Milliliter	0641-6063	ec891c24-bf63-4c25-a55d-ffa3f3d8ec72	1	2012-07-24
0641-6063-10	ML - Milliliter	0641-6063	3864dc11-ac70-4138-b09c-ff4418f7f72a	1	2012-07-24
0641-6063-25	ML - Milliliter	0641-6063	9fc17770-9feb-45ba-a96d-9313c53a0adc	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MIDAZOLAM HYDROCHLORIDE	ACTIVE INGREDIENT	W7TTW573JJ	MIDAZOLAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	2
MIDAZOLAM	ACTIVE MOIETY	R60L0SM5BC	MIDAZOLAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	MIDAZOLAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	MIDAZOLAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	MIDAZOLAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	MIDAZOLAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	MIDAZOLAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	MIDAZOLAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	2

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 56 of 56 · 1,117 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lactated Ringers	SODIUM CHLORIDE, SOLDIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE	Baxter Healthcare Company	5215ec33-8cfe-4885-ae92-e6a12100bd27	2018-01-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Ivy-Dry Super	BENZYL ALCOHOL, CAMPHOR, MENTHOL	Ivy-Dry, Inc.	4792a667-2378-4b3d-968d-9efb1866792f	2017-12-27	Warnings	Exact identifier unii: LKG8494WBH
Homeoplex D	GLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,	Supplement Clinic, LLC.	cd6b48ab-3566-484d-8deb-15ef6f8e7e8f	2017-11-01	Warnings	Exact identifier unii: LKG8494WBH
Homeoplex B	ARSENICUM ALBUM, CALCAREA CARBONICA , IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA, STAPHYSAGRIA	Supplement Clinic, LLC.	e9a9c58e-1b70-4ac8-9d9c-108c628d7664	2017-10-31	Warnings	Exact identifier unii: 451W47IQ8X
Spleen-Pro T018	SPLEEN (SUIS), ARSENICUM ALBUM, CARBO VEGETABILIS, CEANOTHUS AMERICANUS, CHININUM SULPHURICUM, IGNATIA AMARA, IODIUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS	Guangzhou Renuma Medical Systems Co., Ltd	bc2b70bd-2a4a-46fb-b3d8-d69b61056b89	2017-10-26	Warnings	Exact identifier unii: 451W47IQ8X
Female Vitality T010	CIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, OOPHORINUM (SUIS), HYPOPHYSIS SUIS, THYROIDINUM (SUIS), GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIA	Guangzhou Renuma Medical Systems Co., Ltd	694f0c36-b656-471a-9f38-2efb5193e05a	2017-10-20	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	Baxter Healthcare Corporation	ef3e79c5-3f58-4b36-a296-64b7d9a651c1	2017-10-17	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Company	886f889b-f3cf-4197-b307-6cfa88c89436	2017-05-04		Exact identifier unii: 451W47IQ8X
Eye Wash	WATER	CVS Pharmacy	049cee29-7ec2-4d5b-8308-f522acde43a7	2017-03-29	Warnings	Exact identifier unii: 059QF0KO0R
ReHydration	ADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, NATRUM MURIATICUM, SARSAPARILLA, SILICEA, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)	Energetix Corp	9883c502-9782-451e-9eec-c54d7b054f31	2017-01-31	Warnings	Exact identifier unii: 451W47IQ8X
Tox-Chord	ALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUM	Energetix Corp	6b0d1628-b20d-426e-9c84-5cceadca3f45	2016-11-11	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	Baxter Healthcare Company	210dc9ab-d6ca-4552-ac19-1be17792d290	2016-05-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	2a96096d-43cc-49b7-af53-b53c17f41001	2014-07-25	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	b3b4b176-41f0-4ca8-90d4-3fba5707564a	2014-02-21		Exact identifier unii: 451W47IQ8X
TIS-U-SOL	SODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATE	Baxter Healthcare Corporation	9da4121f-d62d-4da4-8dfb-0494da16015f	2014-02-21		Exact identifier unii: 451W47IQ8X
Ringers	SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,	Baxter Healthcare Corporation	e1953d54-818d-46a6-8532-518ebae6d84e	2012-06-13		Exact identifier unii: 451W47IQ8X
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	f09f80bf-2f8b-4420-865d-aec2d5e5cd4d	2012-06-12		Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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