Label: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablet, film coated
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NDC Code(s):
70771-1620-2,
70771-1620-3,
70771-1620-4,
70771-1620-9, view more70771-1621-2, 70771-1621-3, 70771-1621-4, 70771-1621-9, 70771-1622-2, 70771-1622-3, 70771-1622-4, 70771-1622-9, 70771-1709-2, 70771-1709-3, 70771-1709-4, 70771-1709-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated November 28, 2024
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 100 mg/150 mg
Rx Only
30 tablets
Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 133 mg/200 mg
Rx Only
30 tablets
Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 167 mg/250 mg
Rx Only
30 tablets
Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg
Rx Only
30 tablets
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INGREDIENTS AND APPEARANCE
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
emtricitabine and tenofovir disoproxil fumarate tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1620 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EMTRICITABINE (UNII: G70B4ETF4S) (EMTRICITABINE - UNII:G70B4ETF4S) EMTRICITABINE 100 mg TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5) TENOFOVIR DISOPROXIL FUMARATE 150 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) GLYCERYL MONOCAPRYLOCAPRATE (UNII: G7515SW10N) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) KAOLIN (UNII: 24H4NWX5CO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape OVAL Size 14mm Flavor Imprint Code 1364 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1620-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2021 2 NDC:70771-1620-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2021 3 NDC:70771-1620-4 10 in 1 CARTON 07/01/2021 3 NDC:70771-1620-2 10 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 ANDA212689 07/01/2021 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
emtricitabine and tenofovir disoproxil fumarate tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1621 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EMTRICITABINE (UNII: G70B4ETF4S) (EMTRICITABINE - UNII:G70B4ETF4S) EMTRICITABINE 133 mg TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5) TENOFOVIR DISOPROXIL FUMARATE 200 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) GLYCERYL MONOCAPRYLOCAPRATE (UNII: G7515SW10N) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) KAOLIN (UNII: 24H4NWX5CO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape RECTANGLE Size 16mm Flavor Imprint Code 1365 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1621-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2021 2 NDC:70771-1621-4 10 in 1 CARTON 07/01/2021 2 NDC:70771-1621-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:70771-1621-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA212689 07/01/2021 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
emtricitabine and tenofovir disoproxil fumarate tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1622 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EMTRICITABINE (UNII: G70B4ETF4S) (EMTRICITABINE - UNII:G70B4ETF4S) EMTRICITABINE 167 mg TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5) TENOFOVIR DISOPROXIL FUMARATE 250 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) GLYCERYL MONOCAPRYLOCAPRATE (UNII: G7515SW10N) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) KAOLIN (UNII: 24H4NWX5CO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape CAPSULE (modified capsule) Size 18mm Flavor Imprint Code 1366 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1622-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2021 2 NDC:70771-1622-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2021 3 NDC:70771-1622-4 10 in 1 CARTON 07/01/2021 3 NDC:70771-1622-2 10 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 ANDA212689 07/01/2021 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
emtricitabine and tenofovir disoproxil fumarate tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1709 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EMTRICITABINE (UNII: G70B4ETF4S) (EMTRICITABINE - UNII:G70B4ETF4S) EMTRICITABINE 200 mg TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5) TENOFOVIR DISOPROXIL FUMARATE 300 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) GLYCERYL MONOCAPRYLOCAPRATE (UNII: G7515SW10N) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) KAOLIN (UNII: 24H4NWX5CO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) Product Characteristics Color WHITE (off-white) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 1367 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1709-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/24/2021 2 NDC:70771-1709-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/24/2021 3 NDC:70771-1709-4 10 in 1 CARTON 03/24/2021 3 NDC:70771-1709-2 10 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 ANDA212689 03/24/2021 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (863362789) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1620, 70771-1621, 70771-1622, 70771-1709) , MANUFACTURE(70771-1620, 70771-1621, 70771-1622, 70771-1709)