FDA.reportPublic FDA data

ELIQUIS

Product NDC
71610-811
11-digit product format
716100811
Labeler code
71610
Product ID
71610-811_2d3e63c1-62ea-0c12-e063-6394a90aa931
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
2.5 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
APIXABAN2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3Z9Y7UWC1J
Rxcui1364435, 1364441

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
71610-811-42ELIQUIS1800 in 1 BOTTLETABLET, FILM COATED18002
71610-811-80ELIQUIS180 in 1 BOTTLETABLET, FILM COATED1802
71610-811-83ELIQUIS3600 in 1 BOTTLETABLET, FILM COATED36002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-811-42EA - Each71610-8119b8fc20d-df87-4af2-aa40-05c4fa7e2e7812025-03-04
71610-811-80EA - Each71610-8111947fe87-2ca9-4e7e-9f5a-3619b87982e112025-03-04
71610-811-83EA - Each71610-81192a19125-2731-411e-98a7-cc8eaa9761d012024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-811ELIQUIS (APIXABAN) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]2Current NDC, 3 package rows20250205_1523ab32-2c2c-6501-e063-6394a90aa0b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1364435apixaban 2.5 MG Oral TabletPSN1523ab32-2c2c-6501-e063-6394a90aa0b32
1364441Eliquis 2.5 MG Oral TabletPSN1523ab32-2c2c-6501-e063-6394a90aa0b32
1364441apixaban 2.5 MG Oral Tablet [Eliquis]SBD1523ab32-2c2c-6501-e063-6394a90aa0b32
1364435apixaban 2.5 MG Oral TabletSCD1523ab32-2c2c-6501-e063-6394a90aa0b32
1364441Eliquis 2.5 MG Oral TabletSY1523ab32-2c2c-6501-e063-6394a90aa0b32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-811-42716100811421800 TABLET, FILM COATED in 1 BOTTLE (71610-811-42) 2025-01-27NoNoCurrent
71610-811-8071610081180180 TABLET, FILM COATED in 1 BOTTLE (71610-811-80) 2025-01-27NoNoCurrent
71610-811-83716100811833600 TABLET, FILM COATED in 1 BOTTLE (71610-811-83) 2024-03-28NoNoCurrent