Prescription medicine
Sodium benzoate and sodium phenylacetate First approved as Ucephan
Sodium benzoate and sodium phenylacetate (Ucephan) is a prescription medicine with an FDA approval on record since 1987. FDA's NDC Directory lists it from 5 generic labelers.
- Generic listed
Check it at the source: the sodium benzoate and sodium phenylacetate FDA label on DailyMed (effective December 6, 2025); the NDA 19530 record on Drugs@FDA; every sodium benzoate and sodium phenylacetate label on DailyMed.
Highlights of the record
FDA label of December 6, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageSodium Phenylacetate and Sodium Benzoate Injection is a nitrogen binding agent indicated as adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in pediatric and adult patients with deficiencies in enzymes of the urea cycle.( 1 ) Sodium Phenylacetate and Sodium Benzoate Injection is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperam
Forms and strengths
- 100 mg/ml / 100 mg/ml
Injection (solution) (concentrate); injection.
On the market
- Earliest approval on file
- December 23, 1987 Ucephan, B Braun; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first February 24, 2016; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 5 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 9 through July 30, 2026
What is sodium benzoate and sodium phenylacetate used for?
From the label: indications and usageSodium Phenylacetate and Sodium Benzoate Injection is a nitrogen binding agent indicated as adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in pediatric and adult patients with deficiencies in enzymes of the urea cycle.( 1 ) 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 pharmacologic class: Nitrogen Binding Agent.
Source: FDA drug label (Sodium phenylacetate and Sodium benzoate), Navinta LLC, effective December 6, 2025 (SPL set d20768fe-4516-483a-a082-ff1df9ad1d99), via openFDA; the full label on DailyMed
Is there a generic for sodium benzoate and sodium phenylacetate (Ucephan)?
The FDA approved the first generic sodium benzoate and sodium phenylacetate on February 24, 2016. 4 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists sodium benzoate and sodium phenylacetate from 5 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1987 earliest approval on file
- 2016 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the sodium benzoate and sodium phenylacetate label say about other medicines?
The sodium benzoate and sodium phenylacetate label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Divalproex | drug interactions | DRUG INTERACTIONS Some antibiotics such as penicillin may affect the overall disposition of the infused drug. ( 7 ) Probenecid may affect renal excretion of phenylacetylglutamine and hippurate. ( 7 ) Valproic acid given to patients with urea cycle disorders may exacerbate their condition and antagonize the efficacy of … |
| Probenecid | drug interactions | DRUG INTERACTIONS Some antibiotics such as penicillin may affect the overall disposition of the infused drug. ( 7 ) Probenecid may affect renal excretion of phenylacetylglutamine and hippurate. ( 7 ) Valproic acid given to patients with urea cycle disorders may exacerbate their condition and antagonize the efficacy of … |
| Valproic acid | drug interactions | DRUG INTERACTIONS Some antibiotics such as penicillin may affect the overall disposition of the infused drug. ( 7 ) Probenecid may affect renal excretion of phenylacetylglutamine and hippurate. ( 7 ) Valproic acid given to patients with urea cycle disorders may exacerbate their condition and antagonize the efficacy of … |
Check sodium benzoate and sodium phenylacetate against other medicines
Source: FDA drug label (Sodium phenylacetate and Sodium benzoate), Navinta LLC, effective December 6, 2025 (SPL set d20768fe-4516-483a-a082-ff1df9ad1d99), via openFDA; the full label on DailyMed
What do FAERS reports show for sodium benzoate and sodium phenylacetate?
The FDA Adverse Event Reporting System holds 9 reports that list sodium benzoate and sodium phenylacetate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 3 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other nitrogen binding agents
- the pharmacologic class, with prices and generics
- Sodium benzoate and sodium phenylacetate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other