FDA Orange Book
Is there a generic for Zituvimet XR?
Zituvimet XR 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 XR (sitagliptin and metformin).
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Zituvimet XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 1GM;100MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 1GM;50MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 500MG;50MG | Marketed (Rx) | None | 0 | None |
NDA 216778, 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 XR NDC codes
Questions
Is there a generic for Zituvimet XR?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zituvimet XR (sitagliptin and metformin).
What is the generic name for Zituvimet XR?
The active ingredient in Zituvimet XR 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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