Teriflunomide

Basic Information

Product Name

Teriflunomide

FDA Product Code

0781-5755

Regulatory Information

NDC Product Code

0781-5755

Application Number

ANDA209710

Marketing Category

C73584

Effective Date

October 4, 2022

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

TERIFLUNOMIDE

Quantity: 14 mg in 1 1

Code: 1C058IKG3B

Class Code: ACTIB

Inactive Ingredients

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)

Code: RFW2ET671P

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A CORN

Code: AG9B65PV6B

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

Active Moieties

Code: 1C058IKG3B

Teriflunomide

Basic Information

Regulatory Information

Company Information

Active Ingredients

Inactive Ingredients

STARCH, CORN

HYDROXYPROPYL CELLULOSE (1600000 WAMW)

LACTOSE MONOHYDRATE

MAGNESIUM STEARATE

MICROCRYSTALLINE CELLULOSE

SODIUM STARCH GLYCOLATE TYPE A CORN

FD&C BLUE NO. 2

GLYCERIN

HYPROMELLOSE, UNSPECIFIED

TALC

TITANIUM DIOXIDE

FD&C RED NO. 40

SILICON DIOXIDE

FD&C BLUE NO. 1

Active Moieties

TERIFLUNOMIDE