TERIFLUNOMIDE- teriflunomide tablet, film coated 
Zydus Lifesciences Limited

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Teriflunomide Tablets

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1010-3

Teriflunomide Tablets, 7 mg

30 Tablets

Rx only

7 mg

NDC 70771-1011-3

Teriflunomide Tablets, 14 mg

30 Tablets

Rx only

14 mg
TERIFLUNOMIDE 
teriflunomide tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1010
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TERIFLUNOMIDE (UNII: 1C058IKG3B) (TERIFLUNOMIDE - UNII:1C058IKG3B) TERIFLUNOMIDE7 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE TO OFF WHITE) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorImprint Code 1114
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1010-330 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2023
2NDC:70771-1010-82 in 1 CARTON02/14/2023
2NDC:70771-1010-71 in 1 CARTON
214 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20966802/14/2023
TERIFLUNOMIDE 
teriflunomide tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TERIFLUNOMIDE (UNII: 1C058IKG3B) (TERIFLUNOMIDE - UNII:1C058IKG3B) TERIFLUNOMIDE14 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUE (BLUE TO LIGHT BLUE) Scoreno score
ShapeROUND (ROUND) Size8mm
FlavorImprint Code 1115
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1011-330 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2023
2NDC:70771-1011-82 in 1 CARTON02/14/2023
2NDC:70771-1011-71 in 1 CARTON
214 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20966802/14/2023
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1010, 70771-1011) , MANUFACTURE(70771-1010, 70771-1011)

Revised: 9/2023
Document Id: 28263c9d-627b-4c94-a9d1-35e53be4217f
Set id: 58991a51-d40e-476f-8f5f-ac89e68e7107
Version: 2
Effective Time: 20230927
 
Zydus Lifesciences Limited