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 17 of 50 · 983 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SalineNASALPUBLIX SUPER MARKETS, INC19841567-9511-43d6-ba4e-d1e1bd3481a42025-10-28WarningsExact identifier
unii: 451W47IQ8X
Jacksons Cell Salts KALI MUR 6X 5KALI MURIATICUMZettl Health Inc.41ed34d0-94c3-ce79-e063-6294a90a08cb2025-10-24WarningsExact identifier
unii: 451W47IQ8X
NORMOSOL-M AND DEXTROSEDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATEICU Medical Inc.aba60c84-94d9-46d0-bdbb-25e0c4e8cc412025-10-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
miranda castros HEALING FOR INSECT BITES AND STINGSCALENDULA OFFICINALIS, CALADIUM SEGUINUM, LEDUM PALUSTRE, NATRUM MURIATICUM, PLANTAGO MAJOR, STAPHYSAGRIA, URTICA URENSMIRANDA CASTRO'S SHOP, LLC1f99d32e-2394-411a-e063-6294a90ac4542025-10-23WarningsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical Inc.b96eb740-749a-4d3a-ae63-b8e3947cad302025-10-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium Chloride Normal SaltSODIUM CHLORIDEMethod Pharmaceuticalsce84727a-3677-4bf0-e053-2995a90a3ec82025-10-21WarningsExact identifier
unii: 451W47IQ8X
WalgreensSODIUM CHLORIDEWalgreen Company21dfc2cf-65ae-c3fb-e063-6294a90a0a942025-10-17Exact identifier
unii: 451W47IQ8X
Homeopathic Tea Tree Oil LiceEUCALYPTUS GLOBULUS, NATRUM MURIATICUMDOLGENCORP, LLC0a0c2db2-7eeb-909c-e063-6394a90a7a902025-10-15WarningsExact identifier
unii: 451W47IQ8X
Saline AmpoulesSODIUM CHLORIDE 0.9%Trifecta Pharmaceuticals USA, LLC.ee18ef7c-bb5d-30ec-e053-2a95a90a964e2025-10-13WarningsExact identifier
unii: 451W47IQ8X
EQUATE SALINE PACKETSNASAL CLEANING SALTWALMART INC9e905ecb-d4d5-514a-e053-2a95a90adfbb2025-10-08WarningsExact identifier
unii: 451W47IQ8X
EQUATE NETI POT SINUS WASHNASAL WASHWALMART INC9e90c1c1-4dcd-106e-e053-2995a90afd152025-10-08WarningsExact identifier
unii: 451W47IQ8X
GURUNANDA NASAL SALINENASAL WASHGURUNANDA LLC2b4d78ae-b587-6dfe-e063-6394a90a88762025-10-08WarningsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEBecton Dickinson and Companyca3355f2-2cf0-4f58-bed5-0c4c0a7d35112025-10-08Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Homeopathic Calm DropsARSENIC TRIOXIDE 30C, MATRICARIA CHAMOMILLA12X, ARABICA COFFEE BEAN 30X, POTASSIUM CARBONATE30C, STRYCHNOS IGNATII SEED30X, LACHESIS MUTA VENOM12X, PHOSPHORIC ACID 3X, ANEMONE PULSATILLA 12C, VALERIAN 30C, ACONITUM NAPELLUS 6X, CHLORIDE ION 12X, STRYCHNOS NUX-VOMICA SEED 30CHISTORICAL REMEDIES LLP.69c35bc2-b9a0-4bb4-a56d-0e2d1c3f79582025-10-07WarningsExact identifier
unii: 451W47IQ8X
Homeopathic Moon dropsARSENIC CATION 30X, MATRICARIA CHAMOMILLA 6X, ARABICA COFFEE BEAN 12X, GELSEMIUM SEMPERVIRENS ROOT 12X, STRYCHNOS IGNATII SEED 30X, LYCOPODIUM CLAVATUM SPORE 30X, SODIUM CHLORIDE 30X, STRYCHNOS NUX VOMICA SEED 30X, VALERIAN 12C,Historical Remedies LLP0e7972a5-a930-4a52-8896-02ce810fa90b2025-10-07WarningsExact identifier
unii: 451W47IQ8X
Tri-Relief AntifungalSODIUM CHLORIDE, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIGForces of Nature6fe97b54-8aa3-4d86-9055-0629589a416b2025-10-06WarningsExact identifier
unii: 451W47IQ8X
VirexADENOVIREN NOSODE, ASCLEPIAS TUBEROSA, CALCAREA ARSENICICA, CAMPHORA, COXSACKIE A2 NOSODE, COXSACKIE A3 NOSODE, COXSACKIE A4 NOSODE, COXSACKIE A5 NOSODE, COXSACKIE A7 NOSODE, COXSACKIE B1 NOSODE, COXSACKIE B3 NOSODE, COXSACKIE B4 NOSODE, COXSACKIE B5 NOSODE, CYTOMEGALOVIRUS NOSODE, ECHINACEA PURPUREA, EPSTEIN-BARR VIRUS NOSODE, EUPHRASIA OFFICINALIS, INFLUENZINUM, LAC VACCINUM, MORBILLINUM, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, THUJA OCCIDENTALIS, TRIFOLIUM PRATENSE, VARIOLINUMNutritional Specialties, Inc.4baa5c95-79a6-4ae8-a8c4-1edbf308f92c2025-10-03WarningsExact identifier
unii: 451W47IQ8X
FlumazenilFLUMAZENILProPharma Distribution3f7a30b5-2728-0c82-e063-6394a90a92dd2025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078527
ndc (package): 84549-783-10
ndc (product): 84549-783
rxcui: 204508
spl id: 3f7a30b5-2727-0c82-e063-6394a90a92dd
spl set id: 3f7a30b5-2728-0c82-e063-6394a90a92dd
unii: 40P7XK9392
Jet LagECHINACEA, ALUMINA, ARALIA QUINQUEFOLIA, ARGENTUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IODIUM, KALI CARBONICUM, KALI IODATUM, LYCOPODIUM CLAVATUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOXICODENDRON, SABAL SERRULATA, THYROIDINUM.Newton Laboratories, Inc.9c21c935-4ebc-1efd-e053-2995a90aa1562025-09-18WarningsExact identifier
unii: 451W47IQ8X
GAVILYTE-NPOLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATELupin Pharmaceuticals,Inc.27195187-75a3-431f-90d9-84da1b94e8492025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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