FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
Flumazenil - ProPharma DistributionProPharma Distribution2025-09-23HUMAN PRESCRIPTION DRUG LABEL
FLUMAZENIL INJECTION, USPHenry Schein, Inc.2025-02-14HUMAN PRESCRIPTION DRUG LABEL
Flumazenil - Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.AHikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A2024-04-09HUMAN PRESCRIPTION DRUG LABEL
FLUMAZENIL - HF Acquisition Co. LLC, DBA Health FirstHF Acquisition Co. LLC, DBA Health First2024-01-29HUMAN PRESCRIPTION DRUG LABEL
Flumazenil - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2022-10-13HUMAN PRESCRIPTION DRUG LABEL
FLUMAZENILGeneral Injectables and Vaccines, Inc.2019-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9783-01Flumazenil10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION109
0143-9783-10Flumazenil10 in 1 BOXINJECTION, SOLUTION109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9783FLUMAZENIL INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]9Current NDC, Legacy NDC, 2 package rows20240410_442ed32b-b508-40cc-9915-ff05674566da.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9783-01ML - Milliliter0143-9783c0e64a7c-ce05-452b-a660-024b8b4487c912017-03-06
0143-9783-10ML - Milliliter0143-9783e0d16829-7395-4603-89b0-9710e4a1c1ac12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUMAZENILACTIVE INGREDIENT40P7XK9392FLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
FLUMAZENILACTIVE MOIETY40P7XK9392FLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PFLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KFLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBFLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHFLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
FLUMAZENILACTIVE INGREDIENT40P7XK9392FLUMAZENIL INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]1
FLUMAZENILACTIVE MOIETY40P7XK9392FLUMAZENIL INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PFLUMAZENIL INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUFLUMAZENIL INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBFLUMAZENIL INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFLUMAZENIL INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHFLUMAZENIL INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFLUMAZENIL INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFLUMAZENIL 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 41 of 50 · 983 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FlumazenilFLUMAZENILMedical Purchasing Solutions, LLC9f68c61a-c207-cdbe-e053-2a95a90af5a02023-05-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 204508
unii: 40P7XK9392
Natrum MuriaticumNATRIUM MURIATICUMTrue Botanica, LLC7d2d9129-8683-484d-e053-2a91aa0a6f8f2023-05-01WarningsExact identifier
unii: 451W47IQ8X
DysBio PlusECHINACEA (ANGUSTIFOLIA), ALOE, COLCHICUM AUTUMNALE, COLOCYNTHIS, MERCURIUS CORROSIVUS, NUX VOMICA, ARSENICUM ALBUM, ACETICUM ACIDUM, CHININUM SULPHURICUM, CHOLERA NOSODE, PROTEUS (VULGARIS), COLIBACILLINUM CUM NATRUM MURIATICUM, HELICOBACTER PYLORI, BOTULINUM, SALMONELLA TYPHI NOSODE, MORGAN GAERTNER, CLOSTRIDIUM DIFFICILE, BRUGIA MALAYIDeseret Biologicals, Inc.4dcb84ac-48a4-4e09-a6ff-9748218149002023-04-20WarningsExact identifier
unii: Q40Q9N063P
CosmestatALFALFA, AVENA SATIVA, IODIUM, BOVISTA, FORMALINUM, HYPOPHYSIS SUIS, MANGANUM ACETICUM, NATRUM MURIATICUM, PETROLEUM, PULSATILLA (PRATENSIS), RHUS TOX, TEREBINTHINA, THYROIDINUM (BOVINE), CORTISONE ACETICUMEnergique, Inc.edc8eb65-84b3-433f-8aad-7a741f5637182023-04-17WarningsExact identifier
unii: 451W47IQ8X
Baby Nighttime Mucus Plus Cold ReliefCALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLAHyland's Inc.736b2487-e81d-d172-e053-2a91aa0ab0cf2023-04-17WarningsExact identifier
unii: 451W47IQ8X
RadialginCITRUS LIMONUM, FUCUS VESICULOSUS, HYDRANGEA ARBORESCENS, SODIUM ALGINATE, NATRUM MURIATICUM, PHOSPHORUS, AGATE, RADIUM BROMATUM, X RAYNutritional Specialties, Inc.f1414ae2-4068-4076-bf11-b57a34ba5df22023-04-12WarningsExact identifier
unii: 451W47IQ8X
HPYL PLUSANGELICA ARCHANGELICA, GERANIUM MACULATUM, HYDRASTIS CANADENSIS, SINAPIS NIGRA, SYMPHYTUM OFFICINALE, RATANHIA, ACETICUM ACIDUM, CARBOLICUM ACIDUM, ORNITHOGALUM UMBELLATUM, ABIES CANADENSIS, ANACARDIUM ORIENTALE, BISMUTHUM SUBNITRICUM, CONDURANGO, GRAPHITES, IRIS VERSICOLOR, LYCOPODIUM CLAVATUM, MEZEREUM, URANIUM NITRICUM, EUPHORBIUM OFFICINARUM, NUX VOMICADeseret Biologicals, Inc.a13a91e0-572a-4f9c-b80e-f161f055e6fd2023-04-10WarningsExact identifier
unii: Q40Q9N063P
GlutenstatALFALFA, ZINGIBER OFFICINALE, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, BARLEY (GRAIN), CARBO VEGETABILIS, GLYPHOSATE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, OAT (GRAIN), PULSATILLA (VULGARIS), RYE (GRAIN), WHEAT (GRAIN), GLUTENEnergique, Inc.c6b867b6-74d9-4725-90d7-7d5d1fe611212023-04-05WarningsExact identifier
unii: 451W47IQ8X
AnxietyBORAX, NATRUM MURIATICUM, CAUSTICUM, ELETTARIA CARDAMOMUM, PLUMBUM METALLICUM, SEPIA, LILIUM TIGRINUM, OXYTROPIS LAMBERTIINutritional Specialties, Inc.657ed32f-3ac7-4806-96b4-4c7aa0f65e7f2023-04-03WarningsExact identifier
unii: 451W47IQ8X
Virility LiquescenceAVENA SATIVA, DAMIANA, BERBERIS VULGARIS, EPIMEDIUM GRANDIFLORUM, GLYCERINUM, SABAL SERRULATA, IODIUM, LECITHIN, FERRUM MURIATICUM, NATRUM MURIATICUM, AGNUS CASTUS, BUFO RANA, CINCHONA OFFICINALIS, HUMAN GROWTH HORMONE (HGH), ORCHITINUM (BOVINE), PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, ZINCUM VALERIANICUM, OOPHORINUM (SUIS), SEPIANutritional Specialties, Inc.81cc3e2b-f95e-4ba4-a15f-c07b4def0e2f2023-03-29WarningsExact identifier
unii: 451W47IQ8X
Spleen Thymus LiquescenceCINCHONA OFFICINALIS, QUERCUS GLANDIUM SPIRITUS, CEANOTHUS AMERICANUS, SPLEEN (BOVINE), THYMUS (BOVINE), CHININUM ARSENICOSUM, NATRUM MURIATICUM, HELIANTHUS ANNUUSNutritional Specialties, Inc.bc1cc31e-0e8a-49a2-9654-f00eaa72fc042023-03-24WarningsExact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron1ef4a040-7bee-11e6-8371-424c583030312023-02-20Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8645e304-a71b-5cba-e053-2a91aa0a2d882023-02-20Exact identifier
unii: 451W47IQ8X
EyeClear ProCALC CARB, CALC FLUOR, CAUSTICUM, CINERARIA, EUPHRASIA, NAPHTHALINUM, NAT MUR, PHOS, QUASSIA, SILICEASilver Star Brandsf4d4943b-cb78-aa71-e053-2a95a90ac6382023-02-16WarningsExact identifier
unii: 451W47IQ8X
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTESPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESNovel Laboratories, Inc.29d821ff-389c-41fb-8a27-89bd3f022b822023-02-08Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86463b98-58f5-7f65-e053-2a91aa0ad3a22023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8645f130-6a19-ae73-e053-2991aa0ab05b2023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8645eb60-65d1-9d6c-e053-2991aa0a94ef2023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8644ffef-f0e6-5c06-e053-2a91aa0ae83d2023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86466614-b8ee-2335-e053-2a91aa0aa67c2023-01-23Exact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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