FDA Orange Book
Generic for Hiprex
Hiprex 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 Hiprex is methenamine hippurate. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Hiprex and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Hiprex 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 017681, held by ESJAY PHARMA 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 |
Hiprex NDC codes
Questions
Is there a generic for Hiprex?
Yes. The generic name for Hiprex 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 Hiprex?
The active ingredient in Hiprex 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.