FDA Label for Tenofovir Disoproxil Fumarate
View Indications, Usage & Precautions
Tenofovir Disoproxil Fumarate Product Label
The following document was submitted to the FDA by the labeler of this product Aizant Drug Research Solutions Pvt Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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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)
Package Label.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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