24 HR Glipizide 10 MG Extended Release Oral Tablet
1 INDICATIONS AND USAGE Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glipizide extended-release tablet is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis 1.1 Limitations of Use Glipizide extended-release tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
Rising Pharmaceuticals, Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
GLIPIZIDE extended-release tablets are supplied to provide 2.5 mg, 5 mg, and 10 mg round, biconvex tablets and imprinted with black ink as follows: Table 2:
GLIPIZIDE extended-release tablet Presentations Tablet Strength Tablet Color/ Shape Tablet Markings Package Size NDC Code 2.5 mg blue round biconvex imprinted with “P ” on one side. 2.5 Bottles of 30 NDC 64980-279-03 5 mg white round biconvex imprinted with “P ” on one side. 5 Bottles of 100 NDC 64980-280-01 imprinted with “P ” on one side. 5 Bottles of 500 NDC 64980-280-05 imprinted with “P ” on one side. 5 Bottles of 1000 NDC 64980-280-10 10 mg white round biconvex imprinted with “P ” on one side. 10 Bottles of 100 NDC 64980-281-01 imprinted with “P ” on one side. 10 Bottles of 500 NDC 64980-281-05 imprinted with “P ” on one side. 10 Bottles of 1000 NDC 64980-281-10 Recommended Storage: The tablets should be protected from moisture and humidity. Store at 20° to 25°C (68° to 77º F); [see USP Controlled Room Temperature].
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