saxagliptin 5 MG Oral Tablet Onglyza
1 INDICATIONS AND USAGE ONGLYZA is 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 ONGLYZA is 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 Limitations of Use ONGLYZA is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
AstraZeneca Pharmaceuticals LP
ROUND PINK 5 4215
5 4215 ROUND PINK
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ONGLYZA (
SAXAGLIPTIN) tablets have markings on both sides and are available in the strengths and packages listed in Table 16. Table 16: ONGLYZA Tablet Presentations Tablet Strength film-coated Tablet Color/Shape Tablet Markings Package Size NDC Code 5 mg pink biconvex, round “5” on one side and “4215” on the reverse, in blue ink Bottles of 30 Bottles of 90 0310-6105-30 0310-6105-90 2.5 mg pale yellow to light yellow biconvex, round “2.5” on one side and “4214” on the reverse, in blue ink Bottles of 30 Bottles of 90 0310-6100-30 0310-6100-90 Storage and Handling Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [ see USP Controlled Room Temperature].
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