saxagliptin 2.5 mg
1 INDICATIONS AND USAGE Saxagliptin tablets are a dipeptidyl peptidase-4 (DPP4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1.1 , 14 ) Limitation of use: Not used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. ( 1.2 ) 1.1 Monotherapy and Combination Therapy Saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [ see Clinical Studies (14) ]. 1.2 Limitation of Use Saxagliptin tablets are not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
amneal pharmaceuticals llc
ROUND YELLOW 59
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied
SAXAGLIPTIN tablets, 5 mg, are supplied as brown colored, round shaped, biconvex, film-coated tablets imprinted “60” with black ink on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-060-03 Bottles of 90: NDC 65162-060-09 Bottles of 500: NDC 65162-060-50
SAXAGLIPTIN tablets, 2.5 mg, are supplied as light yellow to yellow colored, round shaped, biconvex, film-coated tablets imprinted “59” with black ink on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-059-03 Bottles of 90: NDC 65162-059-09 Bottles of 500: NDC 65162-059-50 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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