Flumazenil

Product NDC
52584-093
11-digit product format
525840093
Labeler code
52584
Product ID
52584-093_d0cdc095-f183-4e00-b78c-2196a8600977
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flumazenil
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
General Injectables & Vaccines, Inc.
Application
ANDA076256
Marketing category
ANDA
Marketing start
2011-02-18
Marketing end
0000-00-00
Substance
FLUMAZENIL
Active strength
1 mg/10mL
Pharmacologic classes
Benzodiazepine Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52584-093-102020-01-31C16284748780-19d75b9d0-43fc-f424-e053-dadaa90a57ceFlumazenil 0.1 mg/ml injection, USP 10ml Multi Dose Vial

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52584-093-10Flumazenil1 in 1 BAGINJECTION13
52584-093-10Flumazenil10 mL in 1 VIAL, MULTI-DOSEINJECTION103

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FlumazenilACTIVE INGREDIENT40P7XK9392FLUMAZENIL INJECTION [GENERAL INJECTABLES & VACCINES, INC.]2
FlumazenilACTIVE MOIETY40P7XK9392FLUMAZENIL INJECTION [GENERAL INJECTABLES & VACCINES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52584-093FLUMAZENIL INJECTION [GENERAL INJECTABLES & VACCINES, INC.]3Legacy NDC, 2 package rows20170119_bf7d0367-df73-47d2-b4a0-66bbf5e119a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204508flumazenil 0.1 MG/ML Injectable SolutionPSNbf7d0367-df73-47d2-b4a0-66bbf5e119a23
204508flumazenil 0.1 MG/ML Injectable SolutionSCDbf7d0367-df73-47d2-b4a0-66bbf5e119a23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52584-093-10525840093101 in 1 BAGHistorical