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
63ba28ef-5055-461a-99ef-c49e8ece4b54
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 3, 2023
Manufacturers
FDA
MSN LABORATORIES PRIVATE LIMITED
DUNS: 650786952
Products 4
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 Code69539-315
Application NumberANDA209623
Product Classification
M
Marketing Category
C73584
G
Generic Name
Teriflunomide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2019
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TERIFLUNOMIDEActive
Quantity: 7 mg in 1 1
Code: 1C058IKG3B
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
Teriflunomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69539-032
Application NumberANDA209623
Product Classification
M
Marketing Category
C73584
G
Generic Name
Teriflunomide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2019
FDA Product Classification
INGREDIENTS (14)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TERIFLUNOMIDEActive
Quantity: 7 mg in 1 1
Code: 1C058IKG3B
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Teriflunomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69539-316
Application NumberANDA209623
Product Classification
M
Marketing Category
C73584
G
Generic Name
Teriflunomide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2019
FDA Product Classification
INGREDIENTS (10)
TERIFLUNOMIDEActive
Quantity: 14 mg in 1 1
Code: 1C058IKG3B
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Teriflunomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69539-033
Application NumberANDA209623
Product Classification
M
Marketing Category
C73584
G
Generic Name
Teriflunomide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2019
FDA Product Classification
INGREDIENTS (12)
TERIFLUNOMIDEActive
Quantity: 14 mg in 1 1
Code: 1C058IKG3B
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT