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Generic Glucophage XR Availability

Last updated on May 11, 2023.

See also: Generic Glucophage

Glucophage XR is a brand name of metformin, approved by the FDA in the following formulation(s):

GLUCOPHAGE XR (metformin hydrochloride - tablet, extended release;oral)

  • Manufacturer: EMD SERONO INC
    Approval date: October 13, 2000
    Strength(s): 500MG (discontinued) [RLD] [AB1]
  • Manufacturer: EMD SERONO INC
    Approval date: April 11, 2003
    Strength(s): 750MG (discontinued) [RLD] [AB]

All of the above formulations have been discontinued.

Has a generic version of Glucophage XR been approved?

Yes. The following products are equivalent to Glucophage XR:

metformin hydrochloride tablet, extended release;oral

  • Manufacturer: ACTAVIS LABS FL INC
    Approval date: April 12, 2005
    Strength(s): 750MG [AB]
  • Manufacturer: ALIGNSCIENCE PHARMA
    Approval date: March 19, 2018
    Strength(s): 500MG [AB1]
  • Manufacturer: ALKEM LABS LTD
    Approval date: October 22, 2018
    Strength(s): 500MG [AB1], 750MG [AB]
  • Manufacturer: AMNEAL PHARMS NY
    Approval date: January 3, 2008
    Strength(s): 500MG [AB1], 750MG [AB]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: July 20, 2012
    Strength(s): 500MG [AB1], 750MG [AB]
  • Manufacturer: BEXIMCO PHARMS USA
    Approval date: December 13, 2016
    Strength(s): 500MG [AB1], 750MG [AB]
  • Manufacturer: CADILA
    Approval date: April 20, 2005
    Strength(s): 500MG [AB1]
  • Manufacturer: CADILA
    Approval date: April 21, 2005
    Strength(s): 750MG [AB]
  • Manufacturer: CSPC OUYI
    Approval date: April 17, 2008
    Strength(s): 500MG [AB1], 750MG [AB]
  • Manufacturer: GRANULES
    Approval date: March 16, 2018
    Strength(s): 500MG [AB1], 750MG [AB]
  • Manufacturer: INTELLIPHARMACEUTICS
    Approval date: February 23, 2017
    Strength(s): 500MG [AB1], 750MG [AB]
  • Manufacturer: INVENTIA
    Approval date: January 18, 2012
    Strength(s): 500MG [AB1]
  • Manufacturer: MACLEODS PHARMS LTD
    Approval date: December 7, 2016
    Strength(s): 500MG [AB1], 750MG [AB]
  • Manufacturer: MARKSANS PHARMA
    Approval date: April 29, 2016
    Strength(s): 500MG [AB1], 750MG [AB]
  • Manufacturer: NOSTRUM PHARMS LLC
    Approval date: July 26, 2006
    Strength(s): 500MG [AB1]
  • Manufacturer: NOSTRUM PHARMS LLC
    Approval date: December 12, 2011
    Strength(s): 750MG [AB]
  • Manufacturer: PRINSTON INC
    Approval date: September 10, 2018
    Strength(s): 500MG [AB1], 750MG [AB]
  • Manufacturer: SANDOZ
    Approval date: December 14, 2004
    Strength(s): 500MG [AB1]
  • Manufacturer: SUN PHARM INDS (IN)
    Approval date: February 9, 2006
    Strength(s): 500MG [AB1], 750MG [AB]
  • Manufacturer: TEVA
    Approval date: June 18, 2004
    Strength(s): 500MG [AB1]
  • Manufacturer: TEVA
    Approval date: April 12, 2005
    Strength(s): 750MG [AB]
  • Manufacturer: UNICHEM
    Approval date: August 11, 2021
    Strength(s): 500MG [AB1], 750MG [AB]
  • Manufacturer: YICHANG HUMANWELL
    Approval date: September 24, 2018
    Strength(s): 500MG [AB1], 750MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Glucophage XR. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQ.

Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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