FDA.reportPublic FDA data

ELIQUIS

Product NDC
0003-0893
11-digit product format
000030893
Labeler code
0003
Product ID
0003-0893_f96cb5ea-74e9-4751-883d-d18ef0d83640
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
apixaban
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
E.R. Squibb & Sons, L.L.C.
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ELIQUIS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APIXABAN2.5 mg/1

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
0003-0893-21ELIQUIS60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6030
0003-0893-31ELIQUIS10 in 1 BLISTER PACKTABLET, FILM COATED1030
0003-0893-31ELIQUIS10 in 1 CARTONTABLET, FILM COATED1030
0003-0893-91ELIQUIS1 in 1 CARTONTABLET, FILM COATED130
0003-0893-91ELIQUIS14 in 1 BLISTER PACKTABLET, FILM COATED1430

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0003-0893-21EA - Each0003-0893965b5c25-f372-48ca-9880-78606e3473e712013-02-13
0003-0893-31EA - Each0003-0893de96c081-bebd-451a-9c15-e58c56cf588b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
apixabanACTIVE INGREDIENT3Z9Y7UWC1JELIQUIS (APIXABAN) TABLET, FILM COATED [E.R. SQUIBB & SONS, L.L.C.]7
apixabanACTIVE MOIETY3Z9Y7UWC1JELIQUIS (APIXABAN) TABLET, FILM COATED [E.R. SQUIBB & SONS, L.L.C.]7
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKELIQUIS (APIXABAN) TABLET, FILM COATED [E.R. SQUIBB & SONS, L.L.C.]7
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UELIQUIS (APIXABAN) TABLET, FILM COATED [E.R. SQUIBB & SONS, L.L.C.]7
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48ELIQUIS (APIXABAN) TABLET, FILM COATED [E.R. SQUIBB & SONS, L.L.C.]7
ferric oxide redINACTIVE INGREDIENT1K09F3G675ELIQUIS (APIXABAN) TABLET, FILM COATED [E.R. SQUIBB & SONS, L.L.C.]7
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTELIQUIS (APIXABAN) TABLET, FILM COATED [E.R. SQUIBB & SONS, L.L.C.]7
hypromellosesINACTIVE INGREDIENT3NXW29V3WOELIQUIS (APIXABAN) TABLET, FILM COATED [E.R. SQUIBB & SONS, L.L.C.]7
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XELIQUIS (APIXABAN) TABLET, FILM COATED [E.R. SQUIBB & SONS, L.L.C.]7
magnesium stearateINACTIVE INGREDIENT70097M6I30ELIQUIS (APIXABAN) TABLET, FILM COATED [E.R. SQUIBB & SONS, L.L.C.]7
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JELIQUIS (APIXABAN) TABLET, FILM COATED [E.R. SQUIBB & SONS, L.L.C.]7
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPELIQUIS (APIXABAN) TABLET, FILM COATED [E.R. SQUIBB & SONS, L.L.C.]7
triacetinINACTIVE INGREDIENTXHX3C3X673ELIQUIS (APIXABAN) TABLET, FILM COATED [E.R. SQUIBB & SONS, L.L.C.]7
apixabanACTIVE INGREDIENT3Z9Y7UWC1JELIQUIS (APIXABAN) TABLET, FILM COATED [CARDINAL HEALTH]2
apixabanACTIVE MOIETY3Z9Y7UWC1JELIQUIS (APIXABAN) TABLET, FILM COATED [CARDINAL HEALTH]2
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKELIQUIS (APIXABAN) TABLET, FILM COATED [CARDINAL HEALTH]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UELIQUIS (APIXABAN) TABLET, FILM COATED [CARDINAL HEALTH]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48ELIQUIS (APIXABAN) TABLET, FILM COATED [CARDINAL HEALTH]2
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTELIQUIS (APIXABAN) TABLET, FILM COATED [CARDINAL HEALTH]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOELIQUIS (APIXABAN) TABLET, FILM COATED [CARDINAL HEALTH]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XELIQUIS (APIXABAN) TABLET, FILM COATED [CARDINAL HEALTH]2
magnesium stearateINACTIVE INGREDIENT70097M6I30ELIQUIS (APIXABAN) TABLET, FILM COATED [CARDINAL HEALTH]2
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JELIQUIS (APIXABAN) TABLET, FILM COATED [CARDINAL HEALTH]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPELIQUIS (APIXABAN) TABLET, FILM COATED [CARDINAL HEALTH]2
triacetinINACTIVE INGREDIENTXHX3C3X673ELIQUIS (APIXABAN) TABLET, FILM COATED [CARDINAL HEALTH]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0003-0893ELIQUIS (APIXABAN) TABLET, FILM COATED ELIQUIS 30-DAY STARTER PACK (APIXABAN) KIT [E.R. SQUIBB & SONS, L.L.C.]30Current NDC, Legacy NDC, 5 package rows20250504_e9481622-7cc6-418a-acb6-c5450daae9b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1364435apixaban 2.5 MG Oral TabletPSNa454cd24-0c6d-46e8-b1e4-19738860617538
1364445apixaban 5 MG Oral TabletPSNa454cd24-0c6d-46e8-b1e4-19738860617538
1364441Eliquis 2.5 MG Oral TabletPSNa454cd24-0c6d-46e8-b1e4-19738860617538
1364447Eliquis 5 MG Oral TabletPSNa454cd24-0c6d-46e8-b1e4-19738860617538
1364441apixaban 2.5 MG Oral Tablet [Eliquis]SBDa454cd24-0c6d-46e8-b1e4-19738860617538
1364447apixaban 5 MG Oral Tablet [Eliquis]SBDa454cd24-0c6d-46e8-b1e4-19738860617538
1364435apixaban 2.5 MG Oral TabletSCDa454cd24-0c6d-46e8-b1e4-19738860617538
1364445apixaban 5 MG Oral TabletSCDa454cd24-0c6d-46e8-b1e4-19738860617538
1364441Eliquis 2.5 MG Oral TabletSYa454cd24-0c6d-46e8-b1e4-19738860617538
1364447Eliquis 5 MG Oral TabletSYa454cd24-0c6d-46e8-b1e4-19738860617538
1992428{74 (apixaban 5 MG Oral Tablet [Eliquis]) } Pack [Eliquis 30-Day Starter Pack]BPCKe9481622-7cc6-418a-acb6-c5450daae9b030
1992427{74 (apixaban 5 MG Oral Tablet) } PackGPCKe9481622-7cc6-418a-acb6-c5450daae9b030
1364435apixaban 2.5 MG Oral TabletPSNe9481622-7cc6-418a-acb6-c5450daae9b030
1992427apixaban 30-Day Starter PackPSNe9481622-7cc6-418a-acb6-c5450daae9b030
1364445apixaban 5 MG Oral TabletPSNe9481622-7cc6-418a-acb6-c5450daae9b030
1364441Eliquis 2.5 MG Oral TabletPSNe9481622-7cc6-418a-acb6-c5450daae9b030
1992428Eliquis 30-Day Starter PackPSNe9481622-7cc6-418a-acb6-c5450daae9b030
1364447Eliquis 5 MG Oral TabletPSNe9481622-7cc6-418a-acb6-c5450daae9b030
1364441apixaban 2.5 MG Oral Tablet [Eliquis]SBDe9481622-7cc6-418a-acb6-c5450daae9b030
1364447apixaban 5 MG Oral Tablet [Eliquis]SBDe9481622-7cc6-418a-acb6-c5450daae9b030
1364435apixaban 2.5 MG Oral TabletSCDe9481622-7cc6-418a-acb6-c5450daae9b030
1364445apixaban 5 MG Oral TabletSCDe9481622-7cc6-418a-acb6-c5450daae9b030
1992427apixaban 30-Day Starter PackSYe9481622-7cc6-418a-acb6-c5450daae9b030
1364441Eliquis 2.5 MG Oral TabletSYe9481622-7cc6-418a-acb6-c5450daae9b030
1992428Eliquis 30-Day Starter PackSYe9481622-7cc6-418a-acb6-c5450daae9b030
1364447Eliquis 5 MG Oral TabletSYe9481622-7cc6-418a-acb6-c5450daae9b030
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
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
1364435apixaban 2.5 MG Oral TabletPSNfd383ae7-1e34-44ef-b8f1-ca6906dfbcef1
1364441Eliquis 2.5 MG Oral TabletPSNfd383ae7-1e34-44ef-b8f1-ca6906dfbcef1
1364441apixaban 2.5 MG Oral Tablet [Eliquis]SBDfd383ae7-1e34-44ef-b8f1-ca6906dfbcef1
1364435apixaban 2.5 MG Oral TabletSCDfd383ae7-1e34-44ef-b8f1-ca6906dfbcef1
1364441Eliquis 2.5 MG Oral TabletSYfd383ae7-1e34-44ef-b8f1-ca6906dfbcef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0003-0893-210000308932160 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-0893-21) 2012-12-280000-00-00NoNoCurrent
0003-0893-310000308933110 BLISTER PACK in 1 CARTON (0003-0893-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2012-12-280000-00-00NoNoCurrent
0003-0893-91000030893911 BLISTER PACK in 1 CARTON (0003-0893-91) / 14 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2012-12-280000-00-00YesNoCurrent