FDA Orange Book
Generic for Urispas
Urispas contains flavoxate. 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 Urispas is flavoxate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Urispas products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Discontinued | None | 2 | AB |
NDA 016769, held by ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic flavoxate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PADAGIS US LLC | 076831 | AB (A-rated, therapeutically equivalent) | December 16, 2004 | 100MG |
| EPIC PHARMA LLC | 076835 | AB (A-rated, therapeutically equivalent) | November 30, 2005 | 100MG |
Questions
Is there a generic for Urispas?
Yes. The generic name for Urispas is flavoxate. 2 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 Urispas?
The active ingredient in Urispas is flavoxate, 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.