TENOFOVIR DISOPROXIL FUMARATE tablet, film coated
tenofovir disoproxil fumarate by
Drug Labeling and Warnings
tenofovir disoproxil fumarate by is a Prescription medication manufactured, distributed, or labeled by AIZANT DRUG RESEARCH SOLUTIONS PVT LTD. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
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16 HOW SUPPLIED/STORAGE AND HANDLING
Tenofovir disoproxiltablets, 150 mg, are triangle-shaped, white, film-coated tablets containing 150 mg of tenofovirdisoproxilfumarate, which is equivalent to 123 mg of tenofovir disoproxil, are debossed with "100" onone side and "A" on the other side. Each bottle contains 30 tablets, a desiccant (1g silica gel canisteror sachet), and closed with a child-resistant closure. (NDC: 69025-100-01)
Tenofovir disoproxiltablets, 200 mg, are round-shaped, white, film-coated tablets containing 200 mg of tenofovirdisoproxilfumarate, which is equivalent to 163 mg of tenofovir disoproxil, are debossed with "101" onone side and "A" on the other side. Each bottle contains 30 tablets, a desiccant (1g silica gelcanister or sachet), and closed with a child-resistant closure. (NDC: 69025-101-01)
Tenofovir disoproxiltablets, 250 mg, are capsule-shaped, white, film-coated tablets containing 250 mg of tenofovirdisoproxilfumarate, which is equivalent to 204 mg of tenofovir disoproxil, are debossed with "102" onone side and "A" on the other side. Each bottle contains 30 tablets, a desiccant (1g silica gel canisteror sachet), and closed with a child-resistant closure. (NDC: 69025-102-01)
Tenofovir disoproxiltablets, 300 mg, are almond-shaped, light blue, film-coated tablets containing 300 mg oftenofovir disoproxilfumarate, which is equivalent to 245 mg of tenofovir disoproxil, are debossedwith "103" on one side and "A" on the other side. Each bottle contains 30tablets, a desiccant (1g silica gel canister or sachet), and closed with a child-resistant closure. (NDC: 69025-103-01)
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PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
Tenofovir Disoproxil Fumarate Tablets
NDC: 69025-100-01
150 mg - 30 Tablets
Rx only
Tenofovir Disoproxil Fumarate Tablets
NDC: 69025-101-01
200 mg - 30 Tablets
Rx only
Tenofovir Disoproxil Fumarate Tablets
NDC: 69025-102-01
250 mg - 30 Tablets
Rx only
Tenofovir Disoproxil Fumarate Tablets
NDC: 69025-103-01
300 mg - 30 Tablets
Rx only
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INGREDIENTS AND APPEARANCE
TENOFOVIR DISOPROXIL FUMARATE
tenofovir disoproxil fumarate tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 69025-100 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength tenofovir disoproxil fumarate (UNII: OTT9J7900I) (tenofovir anhydrous - UNII:W4HFE001U5) tenofovir disoproxil fumarate 150 mg Product Characteristics Color white Score no score Shape TRIANGLE Size 10mm Flavor Imprint Code 100;A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 69025-100-01 30 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/26/2018 TENOFOVIR DISOPROXIL FUMARATE
tenofovir disoproxil fumarate tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 69025-101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength tenofovir disoproxil fumarate (UNII: OTT9J7900I) (tenofovir anhydrous - UNII:W4HFE001U5) tenofovir disoproxil fumarate 200 mg Product Characteristics Color white Score no score Shape ROUND Size 11mm Flavor Imprint Code 101;A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 69025-101-01 30 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/26/2018 TENOFOVIR DISOPROXIL FUMARATE
tenofovir disoproxil fumarate tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 69025-102 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength tenofovir disoproxil fumarate (UNII: OTT9J7900I) (tenofovir anhydrous - UNII:W4HFE001U5) tenofovir disoproxil fumarate 250 mg Product Characteristics Color white Score no score Shape CAPSULE Size 17mm Flavor Imprint Code 102;A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 69025-102-01 30 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/26/2018 TENOFOVIR DISOPROXIL FUMARATE
tenofovir disoproxil fumarate tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 69025-103 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength tenofovir disoproxil fumarate (UNII: OTT9J7900I) (tenofovir anhydrous - UNII:W4HFE001U5) tenofovir disoproxil fumarate 300 mg Product Characteristics Color BLUE (light blue) Score no score Shape FREEFORM (almond-shaped) Size 17mm Flavor Imprint Code 103;A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 69025-103-01 30 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/26/2018 Labeler - AIZANT DRUG RESEARCH SOLUTIONS PVT LTD (650372951) Registrant - AIZANT DRUG RESEARCH SOLUTIONS PVT LTD (650372951)
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