Teriflunomide
These highlights do not include all the information needed to use TERIFLUNOMIDE TABLETS safely and effectively. See full prescribing information for TERIFLUNOMIDE TABLETS. TERIFLUNOMIDE tablets, for oral use Initial U.S. Approval: 2012
Approved
Approval ID
97563214-8fa8-4eab-aa82-4151a9f6f722
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2022
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
teriflunomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-5747
Application NumberANDA209710
Product Classification
M
Marketing Category
C73584
G
Generic Name
teriflunomide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2022
FDA Product Classification
INGREDIENTS (14)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
TERIFLUNOMIDEActive
Quantity: 7 mg in 1 1
Code: 1C058IKG3B
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
teriflunomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-5755
Application NumberANDA209710
Product Classification
M
Marketing Category
C73584
G
Generic Name
teriflunomide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2022
FDA Product Classification
INGREDIENTS (15)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TERIFLUNOMIDEActive
Quantity: 14 mg in 1 1
Code: 1C058IKG3B
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT