Glycerol phenylbutyrate 1.1 g/mL
Glycerol phenylbutyrate · LIQUID · Novadoz Pharmaceuticals LLC
Glycerol phenylbutyrate is a liquid medication taken by mouth that helps manage urea cycle disorders by reducing ammonia levels in the body. It works by providing an alternative pathway for the body to eliminate excess nitrogen.
Key Facts
- Brand Name
- Glycerol phenylbutyrate
- Generic Name
- Glycerol phenylbutyrate
- NDC Code (Product)
72205-331- Manufacturer
- Novadoz Pharmaceuticals LLC
- Strength
- 1.1 g/mL
- Dosage Form
- LIQUID
- Route
- ORAL
- Marketing Status
- Application #
- ANDA219540
- Marketing Start
- 04/15/2026
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Glycerol phenylbutyrate oral liquid is indicated for use as a nitrogen-binding agent for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Glycerol phenylbutyrate oral liquid must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements). Limitations of Use: Glycerol phenylbutyrate oral liquid is not indicated for the treatment of acute hyperammonemia in patients with UCDs because more rapidly acting interventions are essential to reduce plasma ammonia levels. The safety and efficacy of glycerol phenylbutyrate oral liquid for the treatment of N -acetylglutamate synthase (NAGS) deficiency has not been established. Glycerol phenylbutyrate is a nitrogen-binding agent indicated for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Glycerol phenylbutyrate oral liquid must be used with dietary protein restriction and, in some cases, dietary supp…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Glycerol phenylbutyrate oral liquid should be prescribed by a physician experienced in management of UCDs. For administration and preparation, see full prescribing information. ( 2.1 , 2.6 ) Switching From Sodium Phenylbutyrate Tablets or Powder to Glycerol Phenylbutyrate Oral Liquid : Patients should receive the dosage of glycerol phenylbutyrate oral liquid that contains the same amount of phenylbutyric acid, see full prescribing information for conversion. ( 2.2 ) Initial Dosage in Phenylbutyrate-Naïve Patients ( 2.3 ): Recommended dosage range is 4.5 to 11.2 mL/m 2 /day (5 to 12.4 g/m 2 /day). For patients with some residual enzyme activity not adequately controlled with dietary restriction, the recommended starting dose is 4.5 mL/m 2 /day. Take into account patient's estimated urea synthetic capacity, dietary protein intake, and diet adherence. Dosage Adjustment and Monitoring : Follow plasma ammonia levels to determine the need for dosage titration. ( 2.4 ) Dosage Modifications in Patients with Hepatic Impairment : Start dosage at lower end of range. ( 2.5 , 8.7 ) 2.1 Important Administration Instructions Glycerol phenylbutyrate oral liquid should b…
Contraindications
4 CONTRAINDICATIONS Glycerol phenylbutyrate oral liquid is contraindicated in patients with known hypersensitivity to phenylbutyrate. Signs of hypersensitivity include wheezing, dyspnea, coughing, hypotension, flushing, nausea, and rash. Known hypersensitivity to phenylbutyrate. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Corticosteroids, valproic acid, or haloperidol : May increase plasma ammonia level; monitor ammonia levels closely. ( 7.1 ) Probenecid : May affect renal excretion of metabolites of glycerol phenylbutyrate, including phenylacetylglutamine (PAGN) and PAA. ( 7.2 ) CYP3A4 Substrates with narrow therapeutic index (e.g., alfentanil, quinidine, cyclosporine) : Glycerol phenylbutyrate may decrease exposure; monitor for decreased efficacy of the narrow therapeutic index drug. ( 7.3 ) Midazolam : Decreased exposure; monitor for suboptimal effect of midazolam. ( 7.3 ) 7.1 Potential for Other Drugs to Affect Ammonia Corticosteroids Use of corticosteroids may cause the breakdown of body protein and increase plasma ammonia levels. Monitor ammonia levels closely when corticosteroids and glycerol phenylbutyrate are used concomitantly. Valproic Acid and Haloperidol Hyperammonemia may be induced by haloperidol and by valproic acid. Monitor ammonia levels closely when use of valproic acid or haloperidol is necessary in patients with UCDs. 7.2 Potential for Other Drugs to Affect Glycerol Phenylbutyrate Probenecid Probenecid may inhibit the renal excretion of metabolites of glycero…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Neurotoxicity [see Warnings and Precautions (5.1) ] Pancreatic insufficiency or Intestinal Malabsorption [see Warnings and Precautions (5.2) ] Most common adverse reactions (≥10%) in adults are: diarrhea, flatulence, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Assessment of adverse reactions was based on exposure of 45 adult patients (31 female and 14 male) with UCD subtype deficiencies of ornithine transcarbamylase (OTC, n=40), carbamoyl phosphate synthetase (CPS, n=2), and argininosuccinate synthetase (ASS, n=1) in a randomized, double-blind, active-controlled (glycerol phenylbutyrate vs sodium phenylbutyrate), crossover, 4-week study (Study 1) that…
Frequently Asked Questions
What is Glycerol phenylbutyrate used for?
Glycerol phenylbutyrate is a liquid medication taken by mouth that helps manage urea cycle disorders by reducing ammonia levels in the body. It works by providing an alternative pathway for the body to eliminate excess nitrogen.
Is Glycerol phenylbutyrate a controlled substance?
Glycerol phenylbutyrate is not classified as a controlled substance by the DEA.
What is the generic name for Glycerol phenylbutyrate?
The generic name for Glycerol phenylbutyrate is Glycerol phenylbutyrate. There are 5 other brand versions of Glycerol phenylbutyrate.
What is the NDC code for Glycerol phenylbutyrate 1.1 g/mL?
The NDC (National Drug Code) for Glycerol phenylbutyrate 1.1 g/mL is 72205-331, listed by Novadoz Pharmaceuticals LLC.