Apixaban

Product NDC
0115-1722
11-digit product format
001151722
Labeler code
0115
Product ID
0115-1722_ac3db938-22a3-42a0-ac3a-8628d9e0a7cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Apixaban
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA209810
Marketing category
ANDA
Marketing start
2018-08-31
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
0115-1722-01Apixaban10 in 1 CARTONTABLET, FILM COATED1016
0115-1722-03Apixaban1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100016
0115-1722-13Apixaban60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6016
0115-1722-15Apixaban10 in 1 BLISTER PACKTABLET, FILM COATED1016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1722APIXABAN TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]16Current NDC, 4 package rows20250223_19a60552-374d-4b8b-a8ce-ceae252ea5ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1364435apixaban 2.5 MG Oral TabletPSN19a60552-374d-4b8b-a8ce-ceae252ea5ba16
1364445apixaban 5 MG Oral TabletPSN19a60552-374d-4b8b-a8ce-ceae252ea5ba16
1364435apixaban 2.5 MG Oral TabletSCD19a60552-374d-4b8b-a8ce-ceae252ea5ba16
1364445apixaban 5 MG Oral TabletSCD19a60552-374d-4b8b-a8ce-ceae252ea5ba16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0115-1722-010011517220110 BLISTER PACK in 1 CARTON (0115-1722-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0115-1722-15) 10 blister pack2018-08-31NoNoHistorical
0115-1722-03001151722031000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-1722-03) 2018-08-31NoNoHistorical
0115-1722-130011517221360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-1722-13) 2018-08-31NoNoHistorical
0115-1722-150011517221510 in 1 BLISTER PACKHistorical