Flumazenil

Product NDC
70385-2002
11-digit product format
703852002
Labeler code
70385
Product ID
70385-2002_8117cab2-6600-326b-e053-2991aa0abb9c
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
No
Listing certified through
2020-12-31
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
70385-2002-12020-09-27C16284748780-1ab0e2407-2c37-f274-e053-dbdaa90a6471FLUMAZENIL INJECTION, USP
70385-2002-12020-09-25C16284748780-1ab0e2407-2c37-f274-e053-dbdaa90a6471FLUMAZENIL INJECTION, USP
70385-2002-12020-07-22C16284748780-1ab0e2407-2c37-f274-e053-dbdaa90a6471FLUMAZENIL INJECTION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70385-2002-1Flumazenil1 in 1 BAGINJECTION, SOLUTION11
70385-2002-1Flumazenil5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70385-2002FLUMAZENIL INJECTION, SOLUTION [SINA HEALTH INC]1Legacy NDC, 2 package rows20190205_8117cab2-65ff-326b-e053-2991aa0abb9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204508flumazenil 0.1 MG/ML Injectable SolutionPSN8117cab2-65ff-326b-e053-2991aa0abb9c1
204508flumazenil 0.1 MG/ML Injectable SolutionSCD8117cab2-65ff-326b-e053-2991aa0abb9c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
70385-2002-1703852002011 in 1 BAGHistorical