Metformin Hydrochloride Oral Tablet
1 INDICATIONS AND USAGE Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. ( 1 ) Metformin hydrochloride extended-release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 )
Apotex Corp.
ROUND WHITE Met 500 APO
Met 500 APO ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Metformin hydrochloride tablets, USP are available for oral administration and supplied as follow: Metformin hydrochloride tablets, USP 500 mg white to off-white, capsule shaped, unscored, biconvex, film-coated tablets, imprinted “APO 500” on one side and “MET” on the other side. Bottles of 30 (NDC 60505-0190-3) Bottles of 100 (NDC 60505-0190-0) Bottles of 500 (NDC 60505-0190-1) Bottles of 1,000 (NDC 60505-0190-8) Metformin hydrochloride tablets, USP 850 mg white to off-white, capsule shaped, unscored, biconvex, film-coated tablets, imprinted “APO 850” on one side and plain on the other side. Bottles of 30 (NDC 60505-0191-3) Bottles of 100 (NDC 60505-0191-0) Bottles of 500 (NDC 60505-0191-1) Bottles of 1,000 (NDC 60505-0191-8) Metformin hydrochloride tablets, USP 1,000 mg white to off-white, oval, scored, biconvex, film-coated tablets, imprinted “APO 1000” on one side and plain with a full bisect on the other side. Bottles of 30 (NDC 60505-0192-3) Bottles of 100 (NDC 60505-0192-0) Bottles of 500 (NDC 60505-0192-1) Bottles of 1,000 (NDC 60505-0192-8) Metformin hydrochloride extended-release tablets, USP are available for oral administration and supplied as follow: Metformin hydrochloride extended-release tablets, USP 500 mg white to off-white, capsule shaped, unscored tablets, imprinted “APO” on one side and “XR500” on the other side. Bottles of 100 (NDC 60505-0260-1) Bottles of 500 (NDC 60505-0260-2). Metformin hydrochloride extended-release tablets, USP 750 mg white to off-white, capsule shaped, unscored tablets, imprinted “APO” on one side and “XR750” on the other side. Bottles of 30 (NDC 60505-1329-3) Bottles of 100 (NDC 60505-1329-1) Bottles of 500 (NDC 60505-1329-5). 16.2 Storage Store at 20°Cto 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Dispense in tight, light-resistant containers [see USP].
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