FDA Orange Book
Generic for Urso
Urso contains ursodiol. 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 Urso is ursodiol. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Urso products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 250MG | Discontinued | None | 5 | AB |
NDA 020675, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ursodiol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| GLENMARK PHARMACEUTICALS LTD | 090801 | AB (A-rated, therapeutically equivalent) | July 12, 2011 | 250MG |
| PH HEALTH LTD | 202540 | AB (A-rated, therapeutically equivalent) | February 14, 2013 | 250MG |
| ZYDUS LIFESCIENCES GLOBAL FZE | 211145 | AB (A-rated, therapeutically equivalent) | October 30, 2018 | 250MG |
| STRIDES PHARMA GLOBAL PTE LTD | 213504 | AB (A-rated, therapeutically equivalent) | August 20, 2020 | 250MG |
| EPIC PHARMA LLC | 214717 | AB (A-rated, therapeutically equivalent) | August 14, 2024 | 250MG |
Urso NDC codes
Questions
Is there a generic for Urso?
Yes. The generic name for Urso is ursodiol. 5 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 Urso?
The active ingredient in Urso is ursodiol, 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.