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ELIQUIS

These 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 useELIQUIS (apixaban) tablets for oral suspensionELIQUIS SPRINKLE (apixaban) for oral suspensionInitial U.S. Approval: 2012

Approved
Approval ID

e9481622-7cc6-418a-acb6-c5450daae9b0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 30, 2021

Manufacturers
FDA

E.R. Squibb & Sons, L.L.C.

DUNS: 011550092

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

apixaban

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0003-0894
Application NumberNDA202155
Product Classification
M
Marketing Category
C73594
G
Generic Name
apixaban
Product Specifications
Route of AdministrationORAL
Effective DateMarch 2, 2018
FDA Product Classification

INGREDIENTS (11)

apixabanActive
Quantity: 5 mg in 1 1
Code: 3Z9Y7UWC1J
Classification: ACTIB
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT

apixaban

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0003-3764
Application NumberNDA202155
Product Classification
M
Marketing Category
C73594
G
Generic Name
apixaban
Product Specifications
Effective DateMarch 2, 2018
FDA Product Classification

apixaban

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0003-0893
Application NumberNDA202155
Product Classification
M
Marketing Category
C73594
G
Generic Name
apixaban
Product Specifications
Route of AdministrationORAL
Effective DateMarch 2, 2018
FDA Product Classification

INGREDIENTS (11)

croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
apixabanActive
Quantity: 2.5 mg in 1 1
Code: 3Z9Y7UWC1J
Classification: ACTIB
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT

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ELIQUIS - FDA Drug Approval Details