FLUMAZENIL

Product NDC
51662-1579
11-digit product format
516621579
Labeler code
51662
Product ID
51662-1579_c5da455f-3214-ab11-e053-2995a90a54ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUMAZENIL
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA076955
Marketing category
ANDA
Marketing start
2021-06-28
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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1579-1FLUMAZENIL5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1579FLUMAZENIL INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]1Current NDC, Legacy NDC, 1 package rows20210629_c5da455f-3213-ab11-e053-2995a90a54ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204508flumazenil 0.1 MG/ML Injectable SolutionPSNc5da455f-3213-ab11-e053-2995a90a54ee1
204508flumazenil 0.1 MG/ML Injectable SolutionSCDc5da455f-3213-ab11-e053-2995a90a54ee1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1579-1516621579015 mL in 1 VIAL, MULTI-DOSE (51662-1579-1) 5 ml2021-06-280000-00-00NoNoCurrent