NDC 63323-424-01 - 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: 63323-424
Requested NDC: 63323-424-01
Package NDCs from labels: 63323-424-01, 63323-424-05, 63323-424-10
Manufacturer: HF Acquisition Co LLC, DBA HealthFirst
Effective date: 2026-07-10
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
FLUMAZENIL - HF Acquisition Co LLC, DBA HealthFirst	HF Acquisition Co LLC, DBA HealthFirst	2026-07-10	HUMAN PRESCRIPTION DRUG LABEL
FLUMAZENIL - HF Acquisition Co LLC, DBA HealthFirst	HF Acquisition Co LLC, DBA HealthFirst	2026-07-01	HUMAN PRESCRIPTION DRUG LABEL
Flumazenil - Medical Purchasing Solutions, LLC	Medical Purchasing Solutions, LLC	2026-06-09	HUMAN PRESCRIPTION DRUG LABEL
Flumazenil - Fresenius Kabi USA, LLC	Fresenius Kabi USA, LLC	2025-03-27	HUMAN PRESCRIPTION DRUG LABEL
Flumazenil Injection, USP	REMEDYREPACK INC.	2024-01-11	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63323-424-01	Flumazenil	5 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	5	5
63323-424-05	Flumazenil	10 in 1 TRAY	INJECTION, SOLUTION	10	5
63323-424-10	Flumazenil	1 in 1 CARTON	INJECTION, SOLUTION	1	5
63323-424-10	Flumazenil	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-424	FLUMAZENIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	5	Current NDC, Legacy NDC, 4 package rows	20250416_a72d9fc1-121c-455d-93a9-002378c9968f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-424-05	ML - Milliliter	63323-424	4c154a6a-986f-44a4-b8e3-8ce34cd9324c	1	2013-02-13
63323-424-10	ML - Milliliter	63323-424	30b2ed27-bb05-4e4b-a18d-b8cf9b1b945c	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 [APP PHARMACEUTICALS, LLC]	1
FLUMAZENIL	ACTIVE MOIETY	40P7XK9392	FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	1
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	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 40 of 46 · 918 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
4 Kids Cold and Mucus Nighttime	EUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFUR	Hyland's Inc.	6f7b2585-2f0e-5938-e053-2a91aa0aa9d1	2022-11-21	Warnings	Exact identifier unii: 451W47IQ8X
4 Kids Complete Cold and Mucus	BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE	Hyland's Inc.	ef39fe3d-a42d-4baa-9199-91f664feb432	2022-11-21	Warnings	Exact identifier unii: 451W47IQ8X
Multiple Electrolytes pH 7.4	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE	Fresenius Kabi USA, LLC	84221110-b3f1-42f4-800c-ad1d3b330e9e	2022-11-10	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Multiple Electrolytes pH 5.5	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE	Fresenius Kabi USA, LLC	cf1f5f15-d31d-4a02-8f7e-b289d5ad4b5c	2022-11-10	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Natrum Muriaticum	NATRUM MURIATICUM	Hahnemann Laboratories, INC.	ecf06f13-012c-212d-e053-2995a90a7198	2022-11-08		Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	51da05ce-e3c4-4ef5-a845-dc869152e17f	2022-10-24	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Flumazenil	FLUMAZENIL	Medical Purchasing Solutions, LLC	6671d89f-cc82-c03c-e053-2a91aa0aa5fa	2022-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 204508 unii: 40P7XK9392
Dr Talbots Infant Daily Allergy Relief	ALLIUM CEPA 12X,ARALIA RACEMOSA 12X,EUPHRASIA OFFICINALIS 12X,GALPHIMIA GLAUCA 12X,HISTAMINUM HYDROCHLORICUM 12X,LUFFA OPERCULATA 12X,PULSATILLA 12X,SOLIDAGO 12X,NATRUM MURIATICUM 6X	Talbot's Pharmaceuticals Family Products,LLC.	e8bdcc8a-c947-ff5d-e053-2a95a90a3b92	2022-09-12	Warnings	Exact identifier unii: 451W47IQ8X
Herplex	ANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIA	Nashco Products LLC	6a1322c7-7767-4569-aa22-9d2e36331283	2022-08-30	Warnings	Exact identifier unii: 451W47IQ8X
Kids Cold and Cough Nighttime Grape Flavor	ONION, CHAMOMILE, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS TOP, SULFUR	Hyland's Consumer Health Inc.	e676dbb7-212f-47e3-e053-2995a90af4e1	2022-08-17	Warnings	Exact identifier unii: 451W47IQ8X
Kids Cold and Cough Daytime Grape Flavor	ONION, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS WHOLE, SULFUR	Hyland's Consumer Health Inc.	e65f14cb-5a8e-0ad5-e053-2a95a90a6f5d	2022-08-16	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Saline Kids Mist PediaMeds	SODIUM CHLORIDE	ASCENT CONSUMER PRODUCTS, INC.	e5c5b580-1d9f-3081-e053-2995a90a8031	2022-08-08	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Saline Kids Mist SinuCleanse Breathe	SODIUM CHLORIDE	ASCENT CONSUMER PRODUCTS, INC.	e5c5c313-046f-b0a7-e053-2a95a90a2a07	2022-08-08	Warnings	Exact identifier unii: 451W47IQ8X
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	123bd10a-90c7-499e-97f6-acf7e0f0fb4e	2022-07-29	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Herplex	ANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIA	Nashco Products LLC	fad9615f-7004-415d-9f69-ee9ff95f0067	2022-07-12	Warnings	Exact identifier unii: 451W47IQ8X
BHI Constipation	DIOSCOREA VILLOSA TUBER, SODIUM CHLORIDE, AND STRYCHNOS NUX-VOMICA SEED	MediNatura Inc	0365b75b-fee4-4c1d-89ab-c692bdd73f75	2022-07-07	Warnings	Exact identifier unii: 451W47IQ8X
Natrium Muriaticum 6X	SODIUM CHLORIDE	Seroyal USA	0ebf18de-12fe-0bc4-e054-00144ff88e88	2022-07-07	Warnings	Exact identifier unii: 451W47IQ8X
Erogetone	ARALIA QUINQUEFOLIA, BERBERIS VULGARIS, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIA	Energique, Inc.	1e872ecd-e7a5-463d-9832-47b7046096db	2022-06-28	Warnings	Exact identifier unii: 451W47IQ8X
Cardioplegic Solution	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDE	Fresenius Kabi, USA, LLC	eb360dc4-88d6-4b28-9b61-bc359e16bd22	2022-05-27	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Addiclenz	BETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM	Deseret Biologicals, Inc.	e39235ea-2a2f-44a7-92d6-fb1d428ebabd	2022-05-12	Warnings	Exact identifier unii: Z8IX2SC1OH unii: A2I8C7HI9T

Reported adverse events (FAERS/openFDA)#

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