OTEZLA
These highlights do not include all the information needed to use OTEZLA safely and effectively. See full prescribing information for OTEZLA. OTEZLA (apremilast) tablets, for oral use Initial U.S. approval: 2014
Approved
Approval ID
3acf6751-827d-11e2-9e96-0800200c9a66
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 5, 2021
Manufacturers
FDA
Celgene Corporation
DUNS: 174201137
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
apremilast
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59572-630
Application NumberNDA205437
Product Classification
M
Marketing Category
C73594
G
Generic Name
apremilast
Product Specifications
Route of AdministrationORAL
Effective DateJuly 25, 2019
FDA Product Classification
apremilast
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59572-631
Application NumberNDA205437
Product Classification
M
Marketing Category
C73594
G
Generic Name
apremilast
Product Specifications
Route of AdministrationORAL
Effective DateJuly 25, 2019
FDA Product Classification
INGREDIENTS (5)
APREMILASTActive
Quantity: 30.0 mg in 1 1
Code: UP7QBP99PN
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
apremilast
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59572-632
Application NumberNDA205437
Product Classification
M
Marketing Category
C73594
G
Generic Name
apremilast
Product Specifications
Route of AdministrationORAL
Effective DateJuly 25, 2019
FDA Product Classification