FDA.reportPublic FDA data

ELIQUIS

Product NDC
71610-662
11-digit product format
716100662
Labeler code
71610
Product ID
71610-662_2ceefa5f-84de-f3d9-e063-6394a90a6dc5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
apixaban
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA202155
Marketing category
NDA
Marketing start
2012-12-28
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
ELIQUIS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APIXABAN5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3Z9Y7UWC1J
Rxcui1364445, 1364447

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
71610-662-09ELIQUIS9000 in 1 BOTTLE, PLASTICTABLET, FILM COATED90004
71610-662-18ELIQUIS3000 in 1 BOTTLE, PLASTICTABLET, FILM COATED30004
71610-662-42ELIQUIS1800 in 1 BOTTLE, PLASTICTABLET, FILM COATED18004
71610-662-80ELIQUIS180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-662-09EA - Each71610-66256644cff-13ff-4e95-88ab-a52e8f32a27012023-01-09
71610-662-18EA - Each71610-662dfaba521-da47-4302-843c-97631b6d4bef12022-12-07
71610-662-42EA - Each71610-6628a73cee6-e9fa-4afb-a51f-a402fa05752712025-03-04
71610-662-80EA - Each71610-66286abc57b-fd37-4486-a538-f6d3f42f5bbe12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-662ELIQUIS (APIXABAN) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Current NDC, Legacy NDC, 4 package rows20250201_41a133ef-e461-48ad-8221-b735bdd0ec25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1364445apixaban 5 MG Oral TabletPSN41a133ef-e461-48ad-8221-b735bdd0ec254
1364447Eliquis 5 MG Oral TabletPSN41a133ef-e461-48ad-8221-b735bdd0ec254
1364447apixaban 5 MG Oral Tablet [Eliquis]SBD41a133ef-e461-48ad-8221-b735bdd0ec254
1364445apixaban 5 MG Oral TabletSCD41a133ef-e461-48ad-8221-b735bdd0ec254
1364447Eliquis 5 MG Oral TabletSY41a133ef-e461-48ad-8221-b735bdd0ec254

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-662-09716100662099000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-662-09) 2022-09-080000-00-00NoNoCurrent
71610-662-18716100662183000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-662-18) 2022-10-170000-00-00NoNoCurrent
71610-662-42716100662421800 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-662-42) 2025-01-27NoNoHistorical
71610-662-8071610066280180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-662-80) 2023-02-01NoNoHistorical