FDA Orange Book
Generic for Ammonul
Ammonul contains sodium phenylacetate and sodium benzoate. 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 Ammonul is sodium phenylacetate and sodium benzoate. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Ammonul products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 10%;10% (5GM/50ML;5GM/50ML) | Discontinued | None | 3 | AP |
NDA 020645, held by BAUSCH HEALTH US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic sodium phenylacetate and sodium benzoate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AILEX PHARMACEUTICALS LLC | 207096 | AP (A-rated, therapeutically equivalent) | February 24, 2016 | 10%;10% (5GM/50ML;5GM/50ML) |
| NAVINTA LLC | 205880 | AP (A-rated, therapeutically equivalent) | August 4, 2016 | 10%;10% (5GM/50ML;5GM/50ML) |
| MAIA PHARMACEUTICALS INC | 208521 | AP (A-rated, therapeutically equivalent) | May 8, 2017 | 10%;10% (5GM/50ML;5GM/50ML) |
Questions
Is there a generic for Ammonul?
Yes. The generic name for Ammonul is sodium phenylacetate and sodium benzoate. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Ammonul?
The active ingredient in Ammonul is sodium phenylacetate and sodium benzoate, 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.