apixaban

Product NDC
14445-150
11-digit product format
144450150
Labeler code
14445
Product ID
14445-150_6a6e421b-6ed3-403c-b07d-09dbbd6a487c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
apixaban
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Indoco Remedies Limited
Application
ANDA209898
Marketing category
ANDA
Marketing start
2020-09-16
Substance
APIXABAN
Active strength
5 mg/1
Pharmacologic classes
Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APIXABAN5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3Z9Y7UWC1J
Rxcui1364435, 1364445

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
89fbc7dd-7e16-8a82-0070-9b9487bb8075Product name520260129

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14445-150-05apixaban500 in 1 BOTTLETABLET, FILM COATED5007
14445-150-10apixaban10 in 1 BLISTER PACKTABLET, FILM COATED107
14445-150-18apixaban180 in 1 BOTTLETABLET, FILM COATED1807
14445-150-60apixaban60 in 1 BOTTLETABLET, FILM COATED607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14445-150APIXABAN TABLET, FILM COATED [INDOCO REMEDIES LIMITED ]7Current NDC, Legacy NDC, 4 package rows20210615_095a08ac-cf0e-497e-a682-ddef38d6b29c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1364435apixaban 2.5 MG Oral TabletPSN095a08ac-cf0e-497e-a682-ddef38d6b29c7
1364445apixaban 5 MG Oral TabletPSN095a08ac-cf0e-497e-a682-ddef38d6b29c7
1364435apixaban 2.5 MG Oral TabletSCD095a08ac-cf0e-497e-a682-ddef38d6b29c7
1364445apixaban 5 MG Oral TabletSCD095a08ac-cf0e-497e-a682-ddef38d6b29c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
14445-150-0514445015005500 TABLET, FILM COATED in 1 BOTTLE (14445-150-05) 2020-09-160000-00-00NoNoCurrent
14445-150-101444501501010 TABLET, FILM COATED in 1 BLISTER PACK (14445-150-10) 2020-09-160000-00-00NoNoCurrent
14445-150-1814445015018180 TABLET, FILM COATED in 1 BOTTLE (14445-150-18) 2020-09-160000-00-00NoNoCurrent
14445-150-601444501506060 TABLET, FILM COATED in 1 BOTTLE (14445-150-60) 2020-09-160000-00-00NoNoCurrent