FDA Orange Book
Generic for Riomet
Riomet 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 Riomet is metformin. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Riomet products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 500MG/5ML | Discontinued | None | 4 | AB |
NDA 021591, held by RANBAXY SIGNATURE LLC. 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 |
|---|---|---|---|---|
| SAPTALIS PHARMACEUTICALS LLC | 211309 | AB (A-rated, therapeutically equivalent) | March 3, 2020 | 500MG/5ML |
| VISTAPHARM LLC | 212677 | AB (A-rated, therapeutically equivalent) | August 19, 2022 | 500MG/5ML |
| ANNORA PHARMA PRIVATE LTD | 215008 | AB (A-rated, therapeutically equivalent) | March 13, 2025 | 500MG/5ML |
| BIONPHARMA INC | 219151 | AB (A-rated, therapeutically equivalent) | April 14, 2025 | 500MG/5ML |
Questions
Is there a generic for Riomet?
Yes. The generic name for Riomet is metformin. 4 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 Riomet?
The active ingredient in Riomet 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.