FDA Orange Book
Generic for Urex
Urex contains methenamine hippurate. 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 Urex is methenamine hippurate. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Urex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 1GM | Marketed (Rx) | AB | 5 | AB |
NDA 016151, held by QUAGEN PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic methenamine hippurate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA LTD | 205661 | AB (A-rated, therapeutically equivalent) | July 5, 2016 | 1GM |
| MICRO LABS LTD | 212172 | AB (A-rated, therapeutically equivalent) | August 1, 2019 | 1GM |
| INGENUS PHARMACEUTICALS LLC | 210068 | AB (A-rated, therapeutically equivalent) | November 27, 2020 | 1GM |
| JUBILANT CADISTA PHARMACEUTICALS INC | 217675 | AB (A-rated, therapeutically equivalent) | December 1, 2023 | 1GM |
| ZYDUS LIFESCIENCES LTD | 219661 | AB (A-rated, therapeutically equivalent) | March 10, 2025 | 1GM |
Urex NDC codes
Questions
Is there a generic for Urex?
Yes. The generic name for Urex is methenamine hippurate. 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 Urex?
The active ingredient in Urex is methenamine hippurate, 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.