FDA.reportPublic FDA data

NDC 23360-031 - 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
23360-031
Package NDCs from labels
23360-031-05, 23360-031-10
Manufacturer
Akorn-Strides, LLC
Effective date
2008-05-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Flumazenil - Akorn-Strides, LLCAkorn-Strides, LLC2008-05-13HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23360-031-05Flumazenil10 in 1 CARTONINJECTION101
23360-031-05Flumazenil5 mL in 1 VIALINJECTION51
23360-031-10Flumazenil10 in 1 CARTONINJECTION101
23360-031-10Flumazenil10 mL in 1 VIALINJECTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23360-031FLUMAZENIL (FLUMAZENIL) INJECTION [AKORN-STRIDES, LLC]14 package rows20080521_11882E93-AA62-4D24-895C-6F01D97FC730.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUMAZENILACTIVE INGREDIENT40P7XK9392FLUMAZENIL (FLUMAZENIL) INJECTION [AKORN-STRIDES, LLC]1
FLUMAZENILACTIVE MOIETY40P7XK9392FLUMAZENIL (FLUMAZENIL) INJECTION [AKORN-STRIDES, LLC]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PFLUMAZENIL (FLUMAZENIL) INJECTION [AKORN-STRIDES, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KFLUMAZENIL (FLUMAZENIL) INJECTION [AKORN-STRIDES, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBFLUMAZENIL (FLUMAZENIL) INJECTION [AKORN-STRIDES, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFLUMAZENIL (FLUMAZENIL) INJECTION [AKORN-STRIDES, LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHFLUMAZENIL (FLUMAZENIL) INJECTION [AKORN-STRIDES, LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFLUMAZENIL (FLUMAZENIL) INJECTION [AKORN-STRIDES, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFLUMAZENIL (FLUMAZENIL) INJECTION [AKORN-STRIDES, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RFLUMAZENIL (FLUMAZENIL) INJECTION [AKORN-STRIDES, 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 1 of 1 ยท 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FLUMAZENILFLUMAZENILHF Acquisition Co LLC, DBA HealthFirst56452ba8-521d-1f84-e063-6294a90af6fc2026-07-10Warnings, Adverse reactionsExact identifier
rxcui: 204508
FLUMAZENILFLUMAZENILHF Acquisition Co LLC, DBA HealthFirstc5da455f-3213-ab11-e053-2995a90a54ee2026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 204508
FLUMAZENILFLUMAZENILHF Acquisition Co. LLC, DBA HealthFirst74d007e9-9604-0941-e053-2a91aa0a29c42026-06-19Warnings, Adverse reactionsExact identifier
rxcui: 204508
FlumazenilFLUMAZENILMedical Purchasing Solutions, LLC53d9144a-b7ee-b52a-e063-6294a90a09c52026-06-09Warnings, Adverse reactionsExact identifier
rxcui: 204508
FlumazenilFLUMAZENILProPharma Distribution3eefb01b-3d6a-a3eb-e063-6394a90a48292025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 204508
FlumazenilFLUMAZENILProPharma Distribution3f7a30b5-2728-0c82-e063-6394a90a92dd2025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 204508
FlumazenilFLUMAZENILFresenius Kabi USA, LLCa72d9fc1-121c-455d-93a9-002378c9968f2025-03-27Warnings, Adverse reactionsExact identifier
rxcui: 204508
FLUMAZENILFLUMAZENILHenry Schein, Inc.1855bb03-392f-4a0d-8361-24fc2a0e635e2025-02-14Warnings, Adverse reactionsExact identifier
rxcui: 204508
FLUMAZENILFLUMAZENILHenry Schein, Inc.3ea41cbe-bc07-4c95-8bb2-7dfc2e96a8742025-02-14Warnings, Adverse reactionsExact identifier
rxcui: 204508
FlumazenilFLUMAZENILMedical Purchasing Solutions, LLC28f31b54-ff30-fd0d-e063-6394a90afc182024-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 204508
FlumazenilFLUMAZENILHikma Pharmaceuticals USA Inc.436f5616-9626-4b6a-9deb-2986444179d02024-06-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 204508
FlumazenilFLUMAZENILA-S Medication Solutions2190e8d0-d7ca-4f53-b243-0d2c31979aa82024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 204508
FlumazenilFLUMAZENILHikma Pharmaceuticals USA Inc.442ed32b-b508-40cc-9915-ff05674566da2024-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 204508
FLUMAZENILFLUMAZENILHF Acquisition Co. LLC, DBA Health First744ef484-ef46-8d62-e053-2a91aa0a0c052024-01-29Warnings, Adverse reactionsExact identifier
rxcui: 204508
FlumazenilFLUMAZENILMedical Purchasing Solutions, LLC6673efde-057a-a889-e053-2a91aa0a517b2023-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 204508
FlumazenilFLUMAZENILMedical Purchasing Solutions, LLC9f68c61a-c207-cdbe-e053-2a95a90af5a02023-05-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 204508
FlumazenilFLUMAZENILMedical Purchasing Solutions, LLC6671d89f-cc82-c03c-e053-2a91aa0aa5fa2022-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 204508
FlumazenilFLUMAZENILBaxter Healthcare Corporation8175c1eb-80af-48f1-813c-c8f0e736d8942020-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 204508
E846AB12-124D-8C94-E133-A30C4EB85A6911882E93-AA62-4D24-895C-6F01D97FC7302008-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: E846AB12-124D-8C94-E133-A30C4EB85A69
spl set id: 11882E93-AA62-4D24-895C-6F01D97FC730

Reported adverse events (FAERS/openFDA)#

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