Quick answers
- What is Sodium phenylacetate and sodium benzoate used for?
- The FDA-approved label (Sodium Phenylacetate and Sodium Benzoate, Fosun Pharma USA Inc, May 9, 2024) says: “Sodium Phenylacetate and Sodium Benzoate Injection is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sodium phenylacetate and sodium benzoate have a boxed warning?
- No. None of the 10 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Sodium phenylacetate and sodium benzoate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sodium phenylacetate and sodium benzoate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Sodium phenylacetate and sodium benzoate?
- 7 companies list prescription products of Sodium phenylacetate and sodium benzoate in the FDA NDC Directory, including Omnivium Pharmaceuticals LLC., Zydus Pharmaceuticals USA Inc. and Navinta LLC.
What Sodium phenylacetate and sodium benzoate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Sodium Phenylacetate and Sodium Benzoate Injection is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. …
— FDA label: Sodium Phenylacetate and Sodium Benzoate, Fosun Pharma USA Inc, effective May 9, 2024. Read the full label on DailyMed →
The FDA has 10 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 10 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution, concentrate · Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 10 in the FDA NDC Directory |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Omnivium Pharmaceuticals LLC.2 products
- Zydus Pharmaceuticals USA Inc.2 products
- Navinta LLC2 products
- Fosun Pharma USA Inc.1 product
- MAIA Pharmaceuticals, Inc.1 product
- Ailex Pharmaceuticals, LLC1 product
- Maia Pharmaceuticals1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA215025 SODIUM PHENYLACETATE AND SODIUM BENZOATE | Maia Pharms Inc | June 10, 2021 | — |
Generic approvals (4)
- ANDA207096Ailex Pharms LLC · February 24, 2016
- ANDA205880Navinta LLC · August 4, 2016
- ANDA208521Maia Pharms Inc · May 8, 2017
- ANDA217526Navinta LLC · July 14, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 984118, 2560228 |
|---|---|
| SPL set ID of the quoted label | cee1e9a2-bbe5-2419-e053-2a95a90ac3ef |
| FDA labels (SPL) | 10 |
| FDA applications | NDA215025, 4 ANDA |
| Active ingredients (FDA) | SODIUM BENZOATE / SODIUM PHENYLACETATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Sodium Phenylacetate and Sodium Benzoate, Fosun Pharma USA Inc, effective May 9, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →