FDA Orange Book
Is there a generic for Zituvimet?
Zituvimet contains sitagliptin and 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zituvimet (sitagliptin and metformin).
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Zituvimet products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 1GM;50MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 500MG;50MG | Marketed (Rx) | None | 0 | None |
NDA 216743, held by ZYDUS LIFESCIENCES GLOBAL FZE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zituvimet NDC codes
Questions
Is there a generic for Zituvimet?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zituvimet (sitagliptin and metformin).
What is the generic name for Zituvimet?
The active ingredient in Zituvimet is sitagliptin and 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.
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