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 37 of 46 · 918 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anpituapar	HYPOPHYSIS SUIS, AGNUS CASTUS, BARYTA CARBONICA, CALCAREA CARBONICA, IODIUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SEPIA, THYROIDINUM (SUIS), LAC CANINUM, ADRENOCORTICOTROPHIN	Energique, Inc.	c0ed2996-8eb5-43f7-b3cc-17477af7f7e9	2023-07-13	Warnings	Exact identifier unii: 451W47IQ8X
Pneumotox	TRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,	BioActive Nutritional, Inc.	f8846fb1-92e5-4f8e-b3b3-bc620df90a62	2023-07-12	Warnings	Exact identifier unii: 451W47IQ8X
Thyrostat	FUCUS VESICULOSUS, SPONGIA TOSTA, HYPOPHYSIS SUIS, THYROIDINUM (SUIS), ARSENICUM IODATUM, BARYTA CARBONICA, IODIUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM	Energique, Inc.	5c41b36c-e28f-4d60-b9b9-6b888d55ea95	2023-07-12	Warnings	Exact identifier unii: 451W47IQ8X
Introvert Formula	PASSIFLORA INCARNATA, PULSATILLA (PRATENSIS), IGNATIA AMARA, NATRUM MURIATICUM, DUODENUM (SUIS), PETROLEUM, SULPHUR	Nutritional Specialties, Inc.	522148c9-0bc0-44c9-8876-70051224c951	2023-07-11	Warnings	Exact identifier unii: 451W47IQ8X
Aceticum acidum	ACETIC ACID	Boiron	69214a87-0b8c-702d-e053-2a91aa0a3416	2023-07-03		Exact identifier unii: Q40Q9N063P
Hypercalm-Mental Focus	CHAMOMILLA, ECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, ACONITUM NAPELLUS, ADRENALINUM, ARGENTUM NIT., ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, HYOSCYAMUS NIGER, IGNATIA AMARA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SCUTELLARIA LATERIFLORA, STAPHYSAGRIA, STRAMONIUM, THERIDION, VERATRUM VIRIDE	Newton Laboratories, Inc.	ff5f22e1-74ee-1eee-e053-6394a90a2678	2023-06-30	Warnings	Exact identifier unii: 451W47IQ8X
Hypercalm-Mental Focus	CHAMOMILLA, ECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, ACONITUM NAPELLUS, ADRENALINUM, ARGENTUM NIT., ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, HYOSCYAMUS NIGER, IGNATIA AMARA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SCUTELLARIA LATERIFLORA, STAPHYSAGRIA, STRAMONIUM, THERIDION, VERATRUM VIRIDE	Newton Laboratories, Inc.	ff604442-4697-e2bb-e053-6394a90a0340	2023-06-30	Warnings	Exact identifier unii: 451W47IQ8X
Natrum muriaticum	SODIUM CHLORIDE	Boiron	86455058-2722-5c0a-e053-2a91aa0ac659	2023-06-26		Exact identifier unii: 451W47IQ8X
Hyperactivity-Mental Focus	ADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORA	Newton Laboratories, Inc.	fecece1f-22bc-21dc-e053-6294a90ad0c3	2023-06-23	Warnings	Exact identifier unii: 451W47IQ8X
Hyperactivity-Mental Focus	ADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORA	Newton Laboratories, Inc.	fed03a1c-0ea8-1f8e-e053-6394a90a04c0	2023-06-23	Warnings	Exact identifier unii: 451W47IQ8X
Hyperactivity-Mental Focus	ADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORA	Newton Laboratories, Inc.	febf610e-e08a-4797-e053-6294a90a3eb5	2023-06-22	Warnings	Exact identifier unii: 451W47IQ8X
PEG-3350 and Electrolytes	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE	A-S Medication Solutions	7a2d8dab-750f-43c1-933c-4169a840c60c	2023-06-20	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Grain and Seed Antigens	AMARANTH, BAMBOO, BARLEY, BUCKWHEAT, CORN, FLAX SEED, LENTILS, MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SESAME, SOYBEAN, SUGARCANE, SUNFLOWER SEED, WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHUR	BioActive Nutritional, Inc.	36ce44a5-e5ac-4eea-b76d-424dcd4e6b07	2023-06-20	Warnings	Exact identifier unii: 451W47IQ8X
Vital Skin Hair Nails	L-ALANINE, L-ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, APIS MELLIFICA, BIOTIN, EPIDERMIS SUIS, GALIUM APARINE, HAMAMELIS VIRGINIANA, HEPAR SUIS, HGH, HYPOPHYSIS SUIS, NATRUM MURIATICUM, PANTOTHENIC ACID, PHOSPHORICUM ACIDUM, RIBOFLAVINUM, THUJA OCCIDENTALIS	Liddell Laboratories, Inc.	3e8a9233-6e65-4023-b3f8-8bca369a9c2a	2023-06-15	Warnings	Exact identifier unii: 451W47IQ8X
Endopar F	CIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, OOPHORINUM (SUIS), HYPOPHYSIS SUIS, THYROIDINUM (SUIS), GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIA	Energique, Inc.	d186ae0e-0dc3-48e7-9e22-6778bb80ad18	2023-06-07	Warnings	Exact identifier unii: 451W47IQ8X
Flumazenil	FLUMAZENIL	Medical Purchasing Solutions, LLC	6673efde-057a-a889-e053-2a91aa0a517b	2023-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 204508 unii: 40P7XK9392
Cyclease PMS	ESTRONE, SODIUM CHLORIDE, SEPIA OFFICINALIS JUICE	Laboratoires Boiron	09ff0633-2992-4aba-96ed-45a69f3ee589	2023-05-30	Warnings	Exact identifier unii: 451W47IQ8X
BACTERIOSTATIC SODIUM CHLORIDE	SODIUM CHLORIDE	Medical Purchasing Solutions, LLC	8a0d24a9-d02a-0379-e053-2a95a90af712	2023-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Histastat Pollen	BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SABADILLA, SINAPIS NIGRA, SOLIDAGO VIRGAUREA, SULPHUR, WYETHIA HELENIOIDES	Energique, Inc.	00478787-ccec-4101-a0da-fd337037c3ee	2023-05-12	Warnings	Exact identifier unii: 451W47IQ8X
Flumazenil	FLUMAZENIL	Medical Purchasing Solutions, LLC	9f68c61a-c207-cdbe-e053-2a95a90af5a0	2023-05-03	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 204508 unii: 40P7XK9392

Reported adverse events (FAERS/openFDA)#

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