NDC Code(s) : 68462-423-15, 68462-423-85, 68462-423-30, 68462-424-15, 68462-424-85, 68462-424-30
Packager : Glenmark Pharmaceuticals Inc., USA

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:68462-423
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
teriflunomide(UNII: 1C058IKG3B)
(teriflunomide - UNII:1C058IKG3B) 		teriflunomide7 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW (light yellow to yellow) Score no score
Shape ROUND (biconvex) Size 6 mm
Flavor Imprint Code G;43
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-423-152 in 1 CARTON 19/01/2023
114 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:68462-423-851 in 1 CARTON 19/01/2023
25 in 1 BLISTER PACK Type 0: Not a Combination Product
3NDC:68462-423-3030 in 1 BOTTLE Type 0: Not a Combination Product19/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209663 01/19/2023
teriflunomideteriflunomide TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-424
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
teriflunomide(UNII: 1C058IKG3B)
(teriflunomide - UNII:1C058IKG3B) 		teriflunomide14 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (biconvex) Size 7 mm
Flavor Imprint Code G;42
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-424-152 in 1 CARTON 19/01/2023
114 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:68462-424-851 in 1 CARTON 19/01/2023
25 in 1 BLISTER PACK Type 0: Not a Combination Product
3NDC:68462-424-3030 in 1 BOTTLE Type 0: Not a Combination Product19/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209663 01/19/2023

LABELER - Glenmark Pharmaceuticals Inc., USA(130597813)

Establishment
Name Address ID/FEI Business Operations
Glenmark Pharmaceuticals Limited 862603186 MANUFACTURE(68462-423, 68462-424), ANALYSIS(68462-423, 68462-424)

PRINCIPAL DISPLAY PANEL

NDC 68462-423-30

Teriflunomide Tablets

7 mg

Pharmacist: Dispense the Medication Guide provided separately to each patient.

Rx only

30 Tablets

7mg bottle 30

PRINCIPAL DISPLAY PANEL

NDC 68462-424-30

Teriflunomide Tablets

14 mg

Pharmacist: Dispense the Medication Guide provided separately to each patient.

Rx only

30 Tablets

14mg bottle 30