FDA Orange Book
Generic for Monurol
Monurol contains fosfomycin. 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 Monurol is fosfomycin. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
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Monurol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for solution, oral | EQ 3GM BASE/PACKET | Discontinued | None | 8 | AA |
NDA 050717, held by ZAMBON SPA ITALY. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fosfomycin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| XIROMED PHARMA ESPANA SL | 212548 | AA (A-rated, therapeutically equivalent) | October 6, 2020 | EQ 3GM BASE/PACKET |
| ALKEM LABORATORIES LTD | 214554 | AA (A-rated, therapeutically equivalent) | October 21, 2021 | EQ 3GM BASE/PACKET |
| CIPLA LTD | 211881 | AA (A-rated, therapeutically equivalent) | January 26, 2022 | EQ 3GM BASE/PACKET |
| AMNEAL EU LTD | 216600 | AA (A-rated, therapeutically equivalent) | March 25, 2024 | EQ 3GM BASE/PACKET |
| PRECISION DOSE INC | 217187 | AA (A-rated, therapeutically equivalent) | June 3, 2025 | EQ 3GM BASE/PACKET |
| AUROBINDO PHARMA LTD | 217608 | AA (A-rated, therapeutically equivalent) | November 14, 2025 | EQ 3GM BASE/PACKET |
| AUCTA PHARMACEUTICALS INC | 217772 | AA (A-rated, therapeutically equivalent) | April 9, 2026 | EQ 3GM BASE/PACKET |
| NOVITIUM PHARMA LLC | 210426 | AA (A-rated, therapeutically equivalent) | August 12, 2026 | EQ 3GM BASE/PACKET |
Questions
Is there a generic for Monurol?
Yes. The generic name for Monurol is fosfomycin. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
What is the generic name for Monurol?
The active ingredient in Monurol is fosfomycin, 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.