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 22 of 50 · 983 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDRA NEBSODIUM CHLORIDEVenture Healthcare Ltd30b184bf-2451-d96b-e063-6294a90a43c72025-03-19WarningsExact identifier
unii: 451W47IQ8X
HYDRA NEBSODIUM CHLORIDELaboratoire Unither30b244c0-84bb-a0a0-e063-6394a90a9dee2025-03-19WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO16 Lactose FreeCALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Products3036922b-0f2c-12ff-e063-6394a90a85782025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO20 Lactose FreeCALC FLUOR, CALC SULPH, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products30394e7e-170f-7b9d-e063-6394a90afcdb2025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO27 Lactose FreeNAT MUR, KALI PHOS, CALC PHOSBestmade Natural Products303b25cc-b559-3841-e063-6294a90a398b2025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO28 Lactose FreeCALC FLUOR, CALC PHOS, CALC SULPH, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEABestmade Natural Products303b4d92-9f75-38a5-e063-6294a90ae93d2025-03-13WarningsExact identifier
unii: 451W47IQ8X
Psora MiasmEGGSHELL MEMBRANE, WHEY PROTEIN, CALCAREA CARBONICA, LYCOPODIUM CLAVATUM, SULPHUR, ARSENICUM ALBUM, CROTON TIGLIUM, GRAPHITES, HYDROCOTYLE ASIATICA, NATRUM MURIATICUMEnergique, Inc.6a12aa49-35fc-41f4-bec8-6f9a20a97caa2025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO4 Lactose FreeCALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Products30220aca-e052-95f3-e063-6294a90a9cea2025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO5 Lactose FreeFERR PHOS, KALI MUR, NAT MUR, KALI SULPHBestmade Natural Products30225814-b9d7-f16a-e063-6294a90a01942025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO6 Lactose FreeFERR PHOS, KALI MUR, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products302292bd-9c38-2638-e063-6294a90a965d2025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO11 Lactose FreeFERR PHOS, KALI MUR, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products3025f91f-bc0a-691c-e063-6294a90ad1362025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO12 Lactose FreeFERR PHOS, NAT MUR, KALI PHOS, MAG PHOSBestmade Natural Products30262ecd-5bd9-80d0-e063-6294a90ab1db2025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO20CALC FLUOR, CALC SULPH, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products300d4674-5c2e-01b6-e063-6294a90acbf92025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO27NAT MUR, KALI PHOS, CALC PHOSBestmade Natural Products300e8ba5-1b16-ad40-e063-6294a90a674d2025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO28CALC FLUOR, CALC PHOS, CALC SULPH, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEABestmade Natural Products300ead4c-6937-d597-e063-6394a90ad6bb2025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO1 Lactose FreeCALC PHOS, FERR PHOS, KALI PHOS, NAT MURBestmade Natural Products3013926f-ecd2-d376-e063-6294a90a47432025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO2 Lactose FreeKALI PHOS, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products3013d3a9-7f20-4d19-e063-6394a90a58142025-03-11WarningsExact identifier
unii: 451W47IQ8X
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Bestmade Natural Products BIO4CALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Products2ffcffd8-94ba-3a4c-e063-6394a90a24ee2025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO5FERR PHOS, KALI MUR, NAT MUR, KALI SULPHBestmade Natural Products2ffd4d8f-75bf-1b9b-e063-6294a90abc362025-03-10WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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