Flumazenil

Product NDC
36000-148
11-digit product format
360000148
Labeler code
36000
Product ID
36000-148_f84ae313-68b9-444b-83de-d9f50157dad2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flumazenil
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA076755
Marketing category
ANDA
Marketing start
2017-10-01
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
36000-148-05Flumazenil5 in 1 PACKAGEINJECTION517
36000-148-05Flumazenil5 mL in 1 VIAL, MULTI-DOSEINJECTION517
36000-148-10Flumazenil5 mL in 1 VIAL, MULTI-DOSEINJECTION517
36000-148-10Flumazenil10 in 1 PACKAGEINJECTION1017
36000-148-25Flumazenil25 in 1 PACKAGEINJECTION2517
36000-148-25Flumazenil5 mL in 1 VIAL, MULTI-DOSEINJECTION517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36000-148-10ML - Milliliter36000-14811296499-2fa0-4c15-8476-10faa777e57e12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36000-148FLUMAZENIL INJECTION [BAXTER HEALTHCARE CORPORATION]16Current NDC, Legacy NDC, 6 package rows20240921_8175c1eb-80af-48f1-813c-c8f0e736d894.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204508flumazenil 0.1 MG/ML Injectable SolutionPSN8175c1eb-80af-48f1-813c-c8f0e736d89417
204508flumazenil 0.1 MG/ML Injectable SolutionSCD8175c1eb-80af-48f1-813c-c8f0e736d89417
204508flumazenil 0.1 MG/ML Injectable SolutionPSN904f7154-433a-4ea1-b622-acf79568d96b5
204508flumazenil 0.1 MG/ML Injectable SolutionSCD904f7154-433a-4ea1-b622-acf79568d96b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36000-148-05360000148055 in 1 PACKAGEHistorical
36000-148-103600001481010 VIAL, MULTI-DOSE in 1 PACKAGE (36000-148-10) / 5 mL in 1 VIAL, MULTI-DOSE2017-10-010000-00-00NoNoCurrent
36000-148-253600001482525 in 1 PACKAGEHistorical