NDC 0143-9783-01 - 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: 0143-9783
Requested NDC: 0143-9783-01
Package NDCs from labels: 0143-9783-01, 0143-9783-10
Manufacturer: ProPharma Distribution
Effective date: 2025-09-23
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Flumazenil - ProPharma Distribution	ProPharma Distribution	2025-09-23	HUMAN PRESCRIPTION DRUG LABEL
FLUMAZENIL INJECTION, USP	Henry Schein, Inc.	2025-02-14	HUMAN PRESCRIPTION DRUG LABEL
Flumazenil - Hikma Pharmaceuticals USA Inc. \| HIKMA FARMACEUTICA (PORTUGAL), S.A	Hikma Pharmaceuticals USA Inc. \| HIKMA FARMACEUTICA (PORTUGAL), S.A	2024-04-09	HUMAN PRESCRIPTION DRUG LABEL
FLUMAZENIL - HF Acquisition Co. LLC, DBA Health First	HF Acquisition Co. LLC, DBA Health First	2024-01-29	HUMAN PRESCRIPTION DRUG LABEL
Flumazenil - Medical Purchasing Solutions, LLC	Medical Purchasing Solutions, LLC	2022-10-13	HUMAN PRESCRIPTION DRUG LABEL
FLUMAZENIL	General Injectables and Vaccines, Inc.	2019-12-31	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0143-9783-01	Flumazenil	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10		9
0143-9783-10	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
0143-9783	FLUMAZENIL INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	9	Current NDC, Legacy NDC, 2 package rows	20240410_442ed32b-b508-40cc-9915-ff05674566da.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9783-01	ML - Milliliter	0143-9783	c0e64a7c-ce05-452b-a660-024b8b4487c9	1	2017-03-06
0143-9783-10	ML - Milliliter	0143-9783	e0d16829-7395-4603-89b0-9710e4a1c1ac	1	2012-07-24

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
FLUMAZENIL	ACTIVE INGREDIENT	40P7XK9392	FLUMAZENIL INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]	1
FLUMAZENIL	ACTIVE MOIETY	40P7XK9392	FLUMAZENIL INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]	1
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	FLUMAZENIL INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]	1
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	FLUMAZENIL INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	FLUMAZENIL INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	FLUMAZENIL INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	FLUMAZENIL INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	FLUMAZENIL INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	FLUMAZENIL INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]	1

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 33 of 50 · 983 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	f55bd888-5e01-474d-871b-24654c070178	2024-07-24	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	83994d0c-8484-4505-abb5-8a384ed12288	2024-07-22	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Acetic Acid	ACETIC ACID	NuCare Pharmaceuticals,Inc.	7470a1ed-bc00-cb52-e053-2a91aa0a5c7d	2024-07-15	Warnings, Adverse reactions	Exact identifier unii: Q40Q9N063P
sodium chloride	SODIUM CHLORIDE	Becton Dickinson and Company	8df7dcf6-8714-6caf-e053-2995a90ab8cc	2024-07-15	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	CODAN US CORPORATION	aa06e286-75c6-4d7a-959f-6008d38aa6e5	2024-06-24	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Flumazenil	FLUMAZENIL	Hikma Pharmaceuticals USA Inc.	436f5616-9626-4b6a-9deb-2986444179d0	2024-06-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA078527 rxcui: 204508 unii: 40P7XK9392
Flumazenil	FLUMAZENIL	A-S Medication Solutions	2190e8d0-d7ca-4f53-b243-0d2c31979aa8	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA078527 rxcui: 204508 unii: 40P7XK9392
Derma Pain Plus	CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOXICODENDRON, SARSAPARILLA (SMILAX REGELII)	Peaceful Mountain, Inc.	6fa79c31-e48e-4c83-baa2-96cef22cfee1	2024-06-13	Warnings	Exact identifier unii: 451W47IQ8X
Cold Sore Rescue	BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA	Peaceful Mountain, Inc.	a7fe6ec7-a758-43cf-b46f-c327e0632fb8	2024-06-13	Warnings	Exact identifier unii: 451W47IQ8X
NATRUM MUR	NATRUM MUR	Rxhomeo Private Limited d.b.a. Rxhomeo, Inc	1a22655a-68f3-4f13-e063-6294a90ae52c	2024-06-05	Warnings	Exact identifier unii: 451W47IQ8X
Mentox HP	AURUM METALLICUM, BARYTA CARBONICA, CALCAREA CARBONICA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS	Energique, Inc.	ebb23637-4931-4563-ab30-99bea0276580	2024-05-28	Warnings	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Lactated Ringers and Dextrose	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATE	Fresenius Kabi USA, LLC	dbed53b7-0109-4561-8342-0178ec8c64b0	2024-05-22	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Lactated Ringers and Dextrose	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE	Fresenius Kabi USA, LLC	1b912c7e-f005-4af4-b683-083440964249	2024-05-22	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	239a5af1-7498-480f-862c-ab7c3d89d183	2024-05-21	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium chloride	SODIUM CHLORIDE	Becton Dickinson and Company	ebc8b008-a8b3-4c41-89e4-b413f7aab89f	2024-05-21	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Allergies	APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM	Newton Laboratories, Inc.	9d5dea47-5103-21a3-e053-2995a90aee78	2024-05-20	Warnings	Exact identifier unii: 451W47IQ8X
Colopar	COLON (SUIS), ARSENICUM ALBUM, CAUSTICUM, IGNATIA AMARA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SEPIA, SILICEA, THUJA OCCIDENTALIS	Energique, Inc.	c47d7203-abcd-4ae5-bf9b-5df07e07d3c1	2024-05-20	Warnings	Exact identifier unii: 451W47IQ8X
Aging Eye Formula	CINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, GERMANIUM METALLICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, NATRUM MURIATICUM	Nutritional Specialties, Inc.	4510fe59-cc28-4585-925f-42508a60abd0	2024-05-13	Warnings	Exact identifier unii: 451W47IQ8X
GI Distress	ACETICUM ACIDUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, COLIBACILLINUM CUM NATRUM MURIATICUM, COLOCYNTHIS, CROTON TIGLIUM, ECHINACEA (ANGUSTIFOLIA), FERRUM METALLICUM, GAMBOGIA, IRIS VERSICOLOR, LAC DEFLORATUM, MERCURIUS VIVUS, NATRUM PHOSPHORICUM, NUX VOMICA, PROTEUS (MIRABILIS), RICINUS COMMUNIS, VERATRUM ALBUM	Deseret Biologicals, Inc.	40df69fa-92ae-4f26-8664-36955cf395c5	2024-05-13	Warnings	Exact identifier unii: Q40Q9N063P
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	47a0313f-36df-4fa6-a828-c9e1946ba9b0	2024-05-08	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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