Flumazenil

Product NDC
84549-784
11-digit product format
845490784
Labeler code
84549
Product ID
84549-784_463dbcb4-9cf0-7191-e063-6294a90adcfb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
flumazenil
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
ProPharma Distribution
Application
ANDA078527
Marketing category
ANDA
Marketing start
2007-01-01
Substance
FLUMAZENIL
Active strength
.1 mg/mL
Pharmacologic classes
Benzodiazepine Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Flumazenil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUMAZENIL.1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii40P7XK9392
Rxcui204508

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84549-784-10Flumazenil5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION52

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204508flumazenil 0.1 MG/ML Injectable SolutionPSN3eefb01b-3d6a-a3eb-e063-6394a90a48292
204508flumazenil 0.1 MG/ML Injectable SolutionSCD3eefb01b-3d6a-a3eb-e063-6394a90a48292

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84549-784-10845490784105 mL in 1 VIAL, MULTI-DOSE (84549-784-10) 5 ml2025-09-16NoNoCurrent