FDA Orange Book
Generic for Glucophage
Glucophage 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 is metformin. 14 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Glucophage products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 1GM | Discontinued | None | 15 | AB |
| tablet, oral | 500MG | Discontinued | None | 15 | AB |
| tablet, oral | 625MG | Discontinued | None | 2 | AB |
| tablet, oral | 750MG | Discontinued | None | 2 | AB |
| tablet, oral | 850MG | Discontinued | None | 15 | AB |
NDA 020357, 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 |
|---|---|---|---|---|
| CHARTWELL SCHEDULED LLC | 075972 | AB (A-rated, therapeutically equivalent) | January 24, 2002 | 1GM, 500MG, 625MG, 750MG, 850MG |
| PHARMAZONE | 076033 | AB (A-rated, therapeutically equivalent) | January 24, 2002 | 1GM, 500MG, 850MG |
| EPIC PHARMA LLC | 075965 | AB (A-rated, therapeutically equivalent) | January 25, 2002 | 1GM, 500MG, 850MG |
| MYLAN PHARMACEUTICALS INC | 075973 | AB (A-rated, therapeutically equivalent) | January 25, 2002 | 1GM, 500MG, 850MG |
| AUROBINDO PHARMA LTD | 077095 | AB (A-rated, therapeutically equivalent) | January 14, 2005 | 1GM, 500MG, 850MG |
| ZYDUS PHARMACEUTICALS USA INC | 077064 | AB (A-rated, therapeutically equivalent) | April 18, 2005 | 1GM, 500MG, 850MG |
| DR REDDYS LABORATORIES INC | 077787 | AB (A-rated, therapeutically equivalent) | August 23, 2006 | 1GM, 500MG, 850MG |
| GRANULES INDIA LTD | 090564 | AB (A-rated, therapeutically equivalent) | April 22, 2010 | 1GM, 500MG, 850MG |
| ALKEM LABORATORIES LTD | 091184 | AB (A-rated, therapeutically equivalent) | November 1, 2010 | 1GM, 500MG, 850MG |
| PHARMAZONE | 090888 | AB (A-rated, therapeutically equivalent) | March 12, 2012 | 1GM, 500MG, 850MG |
| SCIEGEN PHARMACEUTICALS INC | 203769 | AB (A-rated, therapeutically equivalent) | September 11, 2013 | 1GM, 500MG, 625MG, 750MG, 850MG |
| ZYDUS HEALTHCARE USA LLC | 203686 | AB (A-rated, therapeutically equivalent) | August 28, 2014 | 1GM, 500MG, 850MG |
| CSPC OUYI PHARMACEUTICAL CO LTD | 205096 | AB (A-rated, therapeutically equivalent) | July 11, 2016 | 1GM, 500MG, 850MG |
| LAURUS LABS LTD | 209882 | AB (A-rated, therapeutically equivalent) | August 27, 2018 | 1GM, 500MG, 850MG |
| HARMAN FINOCHEM LTD | 213320 | AB (A-rated, therapeutically equivalent) | December 3, 2021 | 1GM, 500MG, 850MG |
Questions
Is there a generic for Glucophage?
Yes. The generic name for Glucophage is metformin. 14 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Glucophage?
The active ingredient in Glucophage 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.