APREMILAST
These highlights do not include all the information needed to use APREMILAST TABLETS safely and effectively. See full prescribing information for APREMILAST TABLETS. APREMILAST tablets, for oral use Initial U.S. Approval: 2014
Approved
Approval ID
6b37f813-113f-48f3-904c-7d14401ab13d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 1, 2021
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
Products 2
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 Code60219-1410
Application NumberANDA211782
Product Classification
M
Marketing Category
C73584
G
Generic Name
APREMILAST
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2021
FDA Product Classification
INGREDIENTS (11)
APREMILASTActive
Quantity: 30 mg in 1 1
Code: UP7QBP99PN
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
APREMILAST
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60219-1744
Application NumberANDA211782
Product Classification
M
Marketing Category
C73584
G
Generic Name
APREMILAST
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2021
FDA Product Classification