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 48 of 50 · 983 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
InterSol	PLATELET ADDITIVE 3	Fenwal, Inc.	a00c4a93-cde2-4753-81f7-0d6fee9fb690	2020-10-20	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
SODIUM CHLORIDE	SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ac0fd44a-3f39-8d7e-e053-2995a90afeec	2020-08-04	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Cardioplegic	CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM CHLORIDE	Baxter Healthcare Corporation	1fd50ce5-2799-4c26-81da-02cf0578dd9e	2020-06-11	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
0.9% SODIUM CHLORIDE	0.9% SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	a62b71db-8ba2-6f6b-e053-2a95a90a29d1	2020-05-21	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
LACTATED RINGERS AND DEXTROSE	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE	HF Acquisition Co LLC, DBA HealthFirst	a62cf623-9b8a-37e0-e053-2995a90add5b	2020-05-21	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Hay Fever	APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, ALFALFA, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, AMMONIUM CARBONICUM, ARALIA RACEMOSA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, BELLIS PERENNIS, BERBERIS VULGARIS, BRYONIA, CALLUNA VULGARIS, FLOS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CISTUS CANADENSIS, DROSERA, DULCAMARA, EUPATORIUM PERFOLIATUM, EUPHRASIA OFFICINALIS, FAGUS SYLVATICA, FRAXINUS AMERICANA, GELSEMIUM SEMPERVIRENS	Newton Laboratories, Inc.	a6045b91-d361-2731-e053-2a95a90a9772	2020-05-18	Warnings	Exact identifier unii: 451W47IQ8X
Isolyte S	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE	B. Braun Medical Inc.	7e8fe27f-ff82-48c1-9bf6-3c589c8e985d	2020-05-14	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
DEXTROSE AND SODIUM CHLORIDE	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE	Fresenius Kabi USA, LLC	b825c9c4-f2fb-4a4a-9d8c-fb020ad07e93	2020-04-30	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
0.9% SODIUM CHLORIDE	0.9% SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	a2b8220f-e33a-51c3-e053-2995a90a0734	2020-04-07	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
0.9% SODIUM CHLORIDE	0.9% SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	a2bba76a-08ce-6902-e053-2995a90ab9c9	2020-04-07	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Dextrose and Electrolyte No. 48	SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, MONOBASIC POTASSIUM PHOSPHATE, SODIUM CHLORIDE AND DEXTROSE MONOHYDRATE	Baxter Healthcare Company	b283a454-0c20-4fbf-92d3-dae1f3cd3cad	2020-02-13	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	fbc01464-8885-4075-af41-911ffec5ae92	2020-01-27	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Flumazenil	FLUMAZENIL	Baxter Healthcare Corporation	8175c1eb-80af-48f1-813c-c8f0e736d894	2020-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 204508 unii: 40P7XK9392
0a13fe98-d3a9-4e03-b087-015864068cd1			b94647e1-7419-445e-9489-77e8eefe2e4c	2019-12-31	Warnings, Adverse reactions	Exact identifier spl id: 0a13fe98-d3a9-4e03-b087-015864068cd1 spl set id: b94647e1-7419-445e-9489-77e8eefe2e4c
Plasma-Lyte A	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE	Baxter Healthcare Corporation	6ec9e61c-2c26-402f-8604-f446b2e34058	2019-08-05	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Dextrose and Sodium Chloride	POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE	Baxter Healthcare Company	c553fed1-3de5-4826-8eff-633b5923bf0b	2019-02-21	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Sodium Chloride	POTASSIUM CHLORIDE AND SODIUM CHLORIDE	Baxter Healthcare Company	becc7410-0a25-49f5-b0c3-240078479dc8	2019-01-11	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Skin Klear Acne Relief	TRIBASIC CALCIUM PHOSPHATE, FUMARIA OFFICINALIS FLOWERING TOP, ARCTIUM LAPPA ROOT, SODIUM CHLORIDE, SAPONARIA OFFICINALIS ROOT, SILICON DIOXIDE, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR, VIOLA TRICOLOR	Homeocare Laboratories	65afbc20-611b-4bc4-a151-c633bec66a82	2018-12-31	Warnings	Exact identifier unii: 451W47IQ8X
H.M.D.	ALLIUM SAT, AVENA, BERBER VULG, LAPPA, PHYTOLACCA, SOLIDAGO, ALUMINA, ARG NIT, BARYTA CARB, BERYLLIUM, CADMIUM MET, CURPRUM MET, FLUORICUM ACIDUM, INDIUM, IODIUM, LITHIUM CARB, MERC SOLUB, NICCOLUM CARB, NITROGENUM OXYGENATUM, PLUMB MET, SELENIUM, STRONTIUM CARB, TITANIUM, ARSENICUM ALB, NAT MUR, NUX VOM	Zorex International	8c53091a-904d-4756-93e4-17143c5b48e9	2018-12-21	Warnings	Exact identifier unii: 451W47IQ8X
Vitality Female	ARALIA QUINQUEFOLIA, AVENA SATIVA, BERBERIS VULGARIS, CAUSTICUM, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIA	Natural Creations, Inc	679ba86d-bf84-4ded-b0bf-d55a0df9faa4	2018-12-21	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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