FDA.reportPublic FDA data

ELIQUIS

Product NDC
50090-1436
11-digit product format
500901436
Labeler code
50090
Product ID
50090-1436_76e8efee-ea1e-460e-8027-443facf02ee9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
apixaban
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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, 1364445, 1364447

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1436-02024-01-05C16284748780-1f386c64a-2250-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ELIQUIS safely and effectively. See full prescribing information for ELIQUIS. ELIQUIS ® (apixaban) tablets, for oral use Initial U.S. Approval: 2012
50090-1436-02023-01-30C16284748780-1f386c64a-2250-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ELIQUIS safely and effectively. See full prescribing information for ELIQUIS. ELIQUIS ® (apixaban) tablets, for oral use Initial U.S. Approval: 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1436-0ELIQUIS60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1436-0EA - Each50090-143640dfe407-ebf2-4da9-a1ab-750cb51973e212018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1436ELIQUIS (APIXABAN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]23Current NDC, Legacy NDC, 1 package rows20241127_33a9046a-41cc-46c1-becc-2ff4d7d71538.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1364435apixaban 2.5 MG Oral TabletPSN33a9046a-41cc-46c1-becc-2ff4d7d7153823
1364445apixaban 5 MG Oral TabletPSN33a9046a-41cc-46c1-becc-2ff4d7d7153823
1364441Eliquis 2.5 MG Oral TabletPSN33a9046a-41cc-46c1-becc-2ff4d7d7153823
1364447Eliquis 5 MG Oral TabletPSN33a9046a-41cc-46c1-becc-2ff4d7d7153823
1364441apixaban 2.5 MG Oral Tablet [Eliquis]SBD33a9046a-41cc-46c1-becc-2ff4d7d7153823
1364447apixaban 5 MG Oral Tablet [Eliquis]SBD33a9046a-41cc-46c1-becc-2ff4d7d7153823
1364435apixaban 2.5 MG Oral TabletSCD33a9046a-41cc-46c1-becc-2ff4d7d7153823
1364445apixaban 5 MG Oral TabletSCD33a9046a-41cc-46c1-becc-2ff4d7d7153823
1364441Eliquis 2.5 MG Oral TabletSY33a9046a-41cc-46c1-becc-2ff4d7d7153823
1364447Eliquis 5 MG Oral TabletSY33a9046a-41cc-46c1-becc-2ff4d7d7153823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1436-05009014360060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1436-0) 2014-11-280000-00-00NoNoCurrent