NDC Code(s) : 0480-3157-56, 0480-3156-56
Packager : Teva Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TeriflunomideTeriflunomide TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-3157
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TERIFLUNOMIDE(UNII: 1C058IKG3B)
(TERIFLUNOMIDE - UNII:1C058IKG3B) 		TERIFLUNOMIDE7 mg
Product Characteristics
Color blue (light) Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code TV;Y13
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0480-3157-5630 in 1 BOTTLE Type 0: Not a Combination Product13/03/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209700 03/13/2023
TeriflunomideTeriflunomide TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-3156
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TERIFLUNOMIDE(UNII: 1C058IKG3B)
(TERIFLUNOMIDE - UNII:1C058IKG3B) 		TERIFLUNOMIDE14 mg
Product Characteristics
Color blue Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code TV;Y12
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0480-3156-5630 in 1 BOTTLE Type 0: Not a Combination Product13/03/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209700 03/13/2023

LABELER - Teva Pharmaceuticals, Inc.(022629579)

PRINCIPAL DISPLAY PANEL

NDC 0480-3157-56

Teriflunomide Tablets

7 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

30 Tablets

1

PRINCIPAL DISPLAY PANEL

NDC 0480-3156-56            Rx only

Teriflunomide Tablets

14 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

30 Tablets

1