Label: TERIFLUNOMIDE tablet, film coated
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NDC Code(s):
70771-1010-3,
70771-1010-7,
70771-1010-8,
70771-1011-3, view more70771-1011-7, 70771-1011-8
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 27, 2023
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INGREDIENTS AND APPEARANCE
TERIFLUNOMIDE
teriflunomide tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1010 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TERIFLUNOMIDE (UNII: 1C058IKG3B) (TERIFLUNOMIDE - UNII:1C058IKG3B) TERIFLUNOMIDE 7 mg Inactive Ingredients Ingredient Name Strength 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 Color WHITE (WHITE TO OFF WHITE) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code 1114 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1010-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/14/2023 2 NDC:70771-1010-8 2 in 1 CARTON 02/14/2023 2 NDC:70771-1010-7 1 in 1 CARTON 2 14 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209668 02/14/2023 TERIFLUNOMIDE
teriflunomide tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1011 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TERIFLUNOMIDE (UNII: 1C058IKG3B) (TERIFLUNOMIDE - UNII:1C058IKG3B) TERIFLUNOMIDE 14 mg Inactive Ingredients Ingredient Name Strength 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 Color BLUE (BLUE TO LIGHT BLUE) Score no score Shape ROUND (ROUND) Size 8mm Flavor Imprint Code 1115 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1011-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/14/2023 2 NDC:70771-1011-8 2 in 1 CARTON 02/14/2023 2 NDC:70771-1011-7 1 in 1 CARTON 2 14 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209668 02/14/2023 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1010, 70771-1011) , MANUFACTURE(70771-1010, 70771-1011)
