Prescription medicine
Carglumic acid Brand names: Carbaglu
Carglumic acid (Carbaglu) is a prescription medicine with an FDA approval on record since 2010. FDA's NDC Directory lists it from 3 generic labelers.
- Generic listed
Check it at the source: the carglumic acid FDA label on DailyMed (effective January 25, 2024, Recordati Rare Diseases); the NDA 22562 record on Drugs@FDA; every carglumic acid label on DailyMed.
Highlights of the record
FDA label of January 25, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageINDICATIONS AND USAGE CARBAGLU is a carbamoyl phosphate synthetase 1 (CPS 1) activator indicated in pediatric and adult patients as: Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency.
Forms and strengths
- 200 mg
Tablet for suspension.
On the market
- Earliest approval on file
- March 18, 2010 Carbaglu, Recordati Rare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first October 13, 2021; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 3 under generic applications, 1 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
- 745 through July 30, 2026
What is carglumic acid used for?
From the label: indications and usageINDICATIONS AND USAGE CARBAGLU is a carbamoyl phosphate synthetase 1 (CPS 1) activator indicated in pediatric and adult patients as: Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency. ( 1.1 ) Maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency. ( 1.1 ) Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA). […]
FDA pharmacologic class: Carbamoyl Phosphate Synthetase 1 Activator.
Source: FDA drug label (Carbaglu), Recordati Rare Diseases, effective January 25, 2024 (SPL set 10175e73-5172-4dde-a508-8a88b7afc0a1), via openFDA; the full label on DailyMed
Is there a generic for carglumic acid (Carbaglu)?
The FDA approved the first generic carglumic acid on October 13, 2021. 2 generic applications are approved; 2 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 carglumic acid from 3 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2010 earliest approval on file
- 2021 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for carglumic acid?
The FDA Adverse Event Reporting System holds 745 reports that list carglumic acid among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 151 are coded as a death and 401 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Carglumic acid side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other