Flumazenil

Product NDC
70385-2021
11-digit product format
703852021
Labeler code
70385
Product ID
70385-2021_4cc7f2af-1ebb-3d01-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
flumazenil
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sina Health Inc
Application
ANDA078527
Marketing category
ANDA
Marketing start
2007-01-01
Marketing end
0000-00-00
Substance
FLUMAZENIL
Active strength
0 mg/mL
Pharmacologic classes
Benzodiazepine Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70385-2021-12020-01-31C16284748780-19d75b9cf-ff29-f424-e053-dadaa90a57ceFLUMAZENIL INJECTION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70385-2021-1Flumazenil5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION51
70385-2021-1Flumazenil1 in 1 BAGINJECTION, SOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70385-2021FLUMAZENIL INJECTION, SOLUTION [SINA HEALTH INC]1Legacy NDC, 2 package rows20170410_4cc7f2af-1eba-3d01-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204508flumazenil 0.1 MG/ML Injectable SolutionPSN4cc7f2af-1eba-3d01-e054-00144ff88e881
204508flumazenil 0.1 MG/ML Injectable SolutionSCD4cc7f2af-1eba-3d01-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
70385-2021-1703852021015 mL in 1 VIAL, MULTI-DOSE5 mlHistorical