FDA Orange Book
Generic for Glucophage XR
Glucophage XR contains metformin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Glucophage XR is metformin. 29 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AB1, AB2, AB3.
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Glucophage XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 500MG | Discontinued | None | 35 | AB1, AB2, AB3 |
| tablet, extended release, oral | 750MG | Discontinued | None | 17 | AB |
NDA 021202, held by EMD SERONO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic metformin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 076269 | AB1 (A-rated, therapeutically equivalent) | June 18, 2004 | 500MG |
| SANDOZ INC | 076873 | AB1 (A-rated, therapeutically equivalent) | December 14, 2004 | 500MG |
| ACTAVIS LABORATORIES FL INC | 076869 | AB (A-rated, therapeutically equivalent) | April 12, 2005 | 750MG |
| TEVA PHARMACEUTICALS USA INC | 076864 | AB (A-rated, therapeutically equivalent) | April 12, 2005 | 750MG |
| ZYDUS LIFESCIENCES LTD | 077060 | AB1 (A-rated, therapeutically equivalent) | April 20, 2005 | 500MG |
| ZYDUS LIFESCIENCES LTD | 077078 | AB (A-rated, therapeutically equivalent) | April 21, 2005 | 750MG |
| NOSTRUM PHARMACEUTICALS LLC | 076756 | AB1 (A-rated, therapeutically equivalent) | July 26, 2006 | 500MG, 750MG |
| CSPC OUYI PHARMACEUTICAL CO LTD | 078321 | AB1 (A-rated, therapeutically equivalent) | April 17, 2008 | 500MG, 750MG |
| LUPIN LTD | 090692 | AB2 (A-rated, therapeutically equivalent) | June 29, 2011 | 500MG |
| ADAPTIS PHARMA PRIVATE LTD | 201991 | AB1 (A-rated, therapeutically equivalent) | January 18, 2012 | 500MG |
| AUROBINDO PHARMA LTD | 079118 | AB1 (A-rated, therapeutically equivalent) | July 20, 2012 | 500MG, 750MG |
| MYLAN PHARMACEUTICALS INC | 200690 | AB2 (A-rated, therapeutically equivalent) | August 1, 2012 | 500MG |
| LUPIN LTD | 091664 | AB3 (A-rated, therapeutically equivalent) | July 19, 2013 | 500MG |
| PHARMAZONE | 090295 | AB1 (A-rated, therapeutically equivalent) | April 29, 2016 | 500MG, 750MG |
| ACTAVIS LABORATORIES FL INC | 203755 | AB3 (A-rated, therapeutically equivalent) | August 1, 2016 | 500MG |
| MACLEODS PHARMACEUTICALS LTD | 206955 | AB1 (A-rated, therapeutically equivalent) | December 7, 2016 | 500MG, 750MG |
| REGCON HOLDINGS LLC | 207427 | AB1 (A-rated, therapeutically equivalent) | December 13, 2016 | 500MG, 750MG |
| PLATINUM PHARMACEUTICALS | 202306 | AB1 (A-rated, therapeutically equivalent) | February 23, 2017 | 500MG, 750MG |
| MPP PHARMA LLC | 203832 | AB2 (A-rated, therapeutically equivalent) | December 26, 2017 | 500MG |
| GRANULES INDIA LTD | 209313 | AB1 (A-rated, therapeutically equivalent) | March 16, 2018 | 500MG, 750MG |
| ALIGNSCIENCE PHARMA INC | 209303 | AB1 (A-rated, therapeutically equivalent) | March 19, 2018 | 500MG |
| PRINSTON PHARMACEUTICAL INC | 208880 | AB1 (A-rated, therapeutically equivalent) | September 10, 2018 | 500MG, 750MG |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 211052 | AB1 (A-rated, therapeutically equivalent) | September 24, 2018 | 500MG, 750MG |
| ALKEM LABORATORIES LTD | 206145 | AB1 (A-rated, therapeutically equivalent) | October 22, 2018 | 500MG, 750MG |
| NOVAST LABORATORIES LTD | 209674 | AB2 (A-rated, therapeutically equivalent) | November 2, 2018 | 500MG |
| QINGDAO BAHEAL PHARMACEUTICAL CO LTD | 209993 | AB2 (A-rated, therapeutically equivalent) | December 27, 2018 | 500MG |
| GLENMARK PHARMACEUTICALS LTD | 212969 | AB3 (A-rated, therapeutically equivalent) | November 25, 2019 | 500MG |
| AJANTA PHARMA LTD | 213651 | AB2 (A-rated, therapeutically equivalent) | April 9, 2020 | 500MG |
| UNICHEM LABORATORIES LTD | 213359 | AB (A-rated, therapeutically equivalent) | August 11, 2021 | 750MG |
| LAURUS LABS LTD | 217631 | AB (A-rated, therapeutically equivalent) | October 5, 2023 | 750MG |
| HARMAN FINOCHEM LTD | 218673 | AB (A-rated, therapeutically equivalent) | July 5, 2024 | 750MG |
Questions
Is there a generic for Glucophage XR?
Yes. The generic name for Glucophage XR is metformin. 29 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AB1, AB2, AB3.
What is the generic name for Glucophage XR?
The active ingredient in Glucophage XR is metformin, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.