NDC 0143-9683-01 - Flumazenil

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: 0143-9683
Requested NDC: 0143-9683-01
Package NDCs from labels: 0143-9683-01, 0143-9683-10
Manufacturer: Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A
Effective date: 2024-06-21
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Flumazenil - Hikma Pharmaceuticals USA Inc. \| HIKMA FARMACEUTICA (PORTUGAL), S.A	Hikma Pharmaceuticals USA Inc. \| HIKMA FARMACEUTICA (PORTUGAL), S.A	2024-06-21	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0143-9683-01	Flumazenil	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10		9
0143-9683-10	Flumazenil	10 in 1 BOX	INJECTION, SOLUTION	10		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9683	FLUMAZENIL INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	9	Current NDC, Legacy NDC, 2 package rows	20240622_436f5616-9626-4b6a-9deb-2986444179d0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9683-01	ML - Milliliter	0143-9683	17da136b-dfa3-4c73-97b1-0237a53e7c7c	1	2018-07-03
0143-9683-10	ML - Milliliter	0143-9683	91c05e3d-651a-420c-808e-87255b9934a0	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUMAZENIL	ACTIVE INGREDIENT	40P7XK9392	FLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]	4
FLUMAZENIL	ACTIVE MOIETY	40P7XK9392	FLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]	4
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	FLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	FLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]	4
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	FLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	FLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	FLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	FLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]	4
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	FLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]	4

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 47 of 47 · 930 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glucose Control T015	SYZYGIUM JAMBOLANUM, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, HYPOPHYSIS SUIS, PANCREAS SUIS, PHASEOLUS, ACETICUM ACIDUM, LACTICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, URANIUM NITRICUM	Guangzhou Renuma Medical Systems Co., Ltd	3fd02c0a-5cf1-4f35-86d0-d5d09e63f39b	2017-10-26	Warnings	Exact identifier unii: Q40Q9N063P
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
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Company	886f889b-f3cf-4197-b307-6cfa88c89436	2017-05-04		Exact identifier unii: 451W47IQ8X
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
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.