GLUCOPHAGE Tablet / Extended-release tablet Ref.[10564] Active ingredients: Metformin

Source: FDA, National Drug Code (US)  Revision Year: 2018 

Product description

GLUCOPHAGE/GLUCOPHAGE XR contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:

Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 • HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.

GLUCOPHAGE tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients povidone and magnesium stearate. In addition, the coating for the 500 mg and 850 mg tablets contains hypromellose and the coating for the 1000 mg tablet contains hypromellose and polyethylene glycol.

GLUCOPHAGE XR contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively.

GLUCOPHAGE XR 500 mg tablets contain the inactive ingredients hypromellose, microcrystalline cellulose, sodium carboxymethyl cellulose, and magnesium stearate.

GLUCOPHAGE XR 750 mg tablets contain the inactive ingredients hypromellose, sodium carboxymethyl cellulose, magnesium stearate and iron oxide pigment red.

Dosage Forms and Strengths

GLUCOPHAGE is available as:

  • Tablets: 500 mg round, white to off-white, film-coated debossed with “BMS 6060” around the periphery on one side and “500” debossed across the face of the other side.
  • Tablets: 850 mg round, white to off-white, film-coated debossed with “BMS 6070” around the periphery on one side and “850” debossed across the face of the other side.
  • Tablets: 1000 mg white, oval, biconvex, film-coated with “BMS 6071” debossed on one side and “1000” debossed on the opposite side and with a bisect line on both sides.

GLUCOPHAGE XR is available as:

  • Extended-release tablets: 500 mg white to off-white, capsule shaped, biconvex, with “BMS 6063” debossed on one side and “500” debossed across the face of the other side.
  • Extended-release tablets: 750 mg pale red and may have a mottled appearance, capsule shaped, biconvex, with “BMS 6064” debossed on one side and “750” debossed on the other side.
How Supplied

Table 12. GLUCOPHAGE/GLUCOPHAGE XR Available Strengths, Units, and Appearance:

GLUCOPHAGE Tablets
500 mg Bottles of 100 NDC 0087-6060-05 round, white to off-white, film-coated debossed with “BMS 6060” around the periphery on one side and “500” debossed across the face of the other side
850 mg Bottles of 100 NDC 0087-6070-05 round, white to off-white, film-coated debossed with “BMS 6070” around the periphery on one side and “850” debossed across the face of the other side
1000 mg Bottles of 100 NDC 0087-6071-11 white, oval, biconvex, film-coated with “BMS 6071” debossed on one side and “1000” debossed on the opposite side and with a bisect line on both sides
GLUCOPHAGE XR Extended-Release Tablets
500 mg Bottles of 100 NDC 0087-6063-13 white to off-white, capsule shaped, biconvex, with “BMS 6063” debossed on one side and “500” debossed across the face of the other side
750 mg Bottles of 100 NDC 0087-6064-13 pale red and may have a mottled appearance, capsule shaped, biconvex, with “BMS 6064” debossed on one side and “750” debossed on the other side

Distributed by: Bristol-Myers Squibb Company, Princeton, NJ 08543, USA

Drugs

Drug Countries
GLUCOPHAGE Albania, Austria, Canada, Cyprus, Germany, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Italy, Malta, Nigeria, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa
 
Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈