FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
FLUMAZENIL - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2026-07-10HUMAN PRESCRIPTION DRUG LABEL
FLUMAZENIL - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2026-07-01HUMAN PRESCRIPTION DRUG LABEL
Flumazenil - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2026-06-09HUMAN PRESCRIPTION DRUG LABEL
Flumazenil - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2025-03-27HUMAN PRESCRIPTION DRUG LABEL
Flumazenil Injection, USPREMEDYREPACK INC.2024-01-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-424-01Flumazenil5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION55
63323-424-05Flumazenil10 in 1 TRAYINJECTION, SOLUTION105
63323-424-10Flumazenil1 in 1 CARTONINJECTION, SOLUTION15
63323-424-10Flumazenil10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-424FLUMAZENIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 4 package rows20250416_a72d9fc1-121c-455d-93a9-002378c9968f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-424-05ML - Milliliter63323-4244c154a6a-986f-44a4-b8e3-8ce34cd9324c12013-02-13
63323-424-10ML - Milliliter63323-42430b2ed27-bb05-4e4b-a18d-b8cf9b1b945c12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUMAZENILACTIVE INGREDIENT40P7XK9392FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
FLUMAZENILACTIVE MOIETY40P7XK9392FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PFLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KFLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBFLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHFLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFLUMAZENIL 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 9 of 50 · 983 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0.9salineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd49e76aca-ca2b-3b95-e063-6394a90a875e2026-02-03WarningsExact identifier
unii: 451W47IQ8X
0.9%salineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd49e7b329-e4e5-6991-e063-6294a90ac8172026-02-03WarningsExact identifier
unii: 451W47IQ8X
Adrenal SupportADRENALINUM, BERBERIS VULGARIS, ARGENTUM NITRICUM, NATRUM MURIATICUM, VANADIUM METALLICUM, OLEUM MORRHUAE, PETROLEUMNaturalCarecee52757-a86e-4251-b65f-954ac85f4e7e2026-01-30WarningsExact identifier
unii: 451W47IQ8X
Vital Female Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SABAL SERRULATA, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.7b15d6fa-eb04-41d2-8a01-6e7408ccf4d32026-01-30WarningsExact identifier
unii: 451W47IQ8X
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
CVS ULTRA FINE MOISTURIZING SALINE MISTNASAL MISTCVS44821c47-63f9-5d0a-e063-6394a90a555d2026-01-29WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDENephron Pharmaceuticals Corporationa4edf2d5-a9ff-30d4-e053-2995a90a56502026-01-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
FUNGAL NAIL TREATMENTFUNGAL NAIL TREATMENTJiangxi He-Oumei Health Industry Co., Ltd.4922f627-167a-1783-e063-6394a90acd6f2026-01-24WarningsExact identifier
unii: Q40Q9N063P
Sodium ChlorideSODIUM CHLORIDEProPharma Distribution48d73434-e65b-dc98-e063-6294a90affa22026-01-20Adverse reactionsExact identifier
unii: 451W47IQ8X
Equate Comfort Flow Sinus washSINUS WASHWALMART INC9e911eef-ca99-9902-e053-2a95a90aab0e2026-01-19WarningsExact identifier
unii: 451W47IQ8X
EQUATE PREMIUM SALINESODIUM CHLORIDE 0.65%Walmart Stores, Inc.1e17f022-f513-140d-e063-6394a90a379e2026-01-19WarningsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLCd98bf9f7-30ec-4927-a577-cabad192cb182026-01-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium Chloride HypertonicitySODIUM CHLORIDECVS Pharmacy9245d842-7f78-42d8-83ba-8eb9ec8dbc0d2026-01-15WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride HypertonicitySODIUM CHLORIDECVS PHARMACYd5cc6cd1-ddf8-4f5b-a021-204cdda0db942026-01-15WarningsExact identifier
unii: 451W47IQ8X
Constipation ReliefALUMINUM OXIDE, BRYONIA ALBA ROOT, SODIUM CHLORIDE, GRAPHITE, SILICON DIOXIDEHomeocare Laboratories62374240-cd14-44e2-9405-5f8996faf0472026-01-12WarningsExact identifier
unii: 451W47IQ8X
LuffaLUFFA, HYDRASTIS CANADENSIS, MERCURIUS SULPH. RUB, ALLIUM CEPA, NATRUM MURITICUM, PHOSPHORUS, EUPATORIUM PERF, STICTAMarco Pharma International LLC.7dbb79de-c3f5-4245-884a-a6bd29bb861c2026-01-12WarningsExact identifier
unii: 451W47IQ8X
Hepaticol Drops 5008HEPATICOL DROPSProfessional Complementary Health Formulas79ee9e37-7853-4560-a87d-cdaefb603bbb2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Weight Management Formula 7534WEIGHT MANAGEMENT FORMULAProfessional Complementary Health Formulasf0406b63-7b97-4b2c-b976-75e8890818c62026-01-08WarningsExact identifier
unii: 451W47IQ8X
Acne Drops 2001ACNE DROPSProfessional Complementary Health Formulas340fc7dc-2aa4-411f-842b-4ce7046717222026-01-08WarningsExact identifier
unii: 451W47IQ8X
Radialgin 6002RADIALGINProfessional Complementary Health Formulas5e7ce7a0-9f43-4a69-89e9-a59692a8de412026-01-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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