Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Teriflunomide
Product Details
NDC Product Code
0378-0628Application Number
ANDA209702Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 24, 2022TeriflunomideActive
Code: 1C058IKG3BClass: ACTIBQuantity: 14 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
Teriflunomide
Product Details
NDC Product Code
0378-0627Application Number
ANDA209702Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 24, 2022STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TeriflunomideActive
Code: 1C058IKG3BClass: ACTIBQuantity: 7 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT