Quick answers
- What is Carglumic acid used for?
- The FDA-approved label (Carbaglu, Recordati Rare Diseases, January 25, 2024) says: “1. INDICATIONS 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. Maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Carglumic acid have a boxed warning?
- No. None of the 4 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Carglumic acid?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Carglumic acid been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Carglumic acid?
- 4 companies list prescription products of Carglumic acid in the FDA NDC Directory, including Recordati Rare Diseases, Burel Pharmaceuticals, LLC and Navinta LLC.
What Carglumic acid is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
1. INDICATIONS 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. Maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency. …
— FDA label: Carbaglu, Recordati Rare Diseases, effective January 25, 2024. Read the full label on DailyMed →
The FDA has 4 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 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, for suspension |
|---|---|
| Route | Oral |
| Prescription products | 4 in the FDA NDC Directory |
| Brand names | Carbaglu |
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.
- Recordati Rare Diseases1 product
- Burel Pharmaceuticals, LLC1 product
- Navinta LLC1 product
- Eton Pharmaceuticals, Inc.1 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 |
|---|---|---|---|
| NDA022562 CARBAGLU | Recordati Rare | March 18, 2010 | 11, latest January 19, 2024 2024: Labeling · 2021: Labeling · 2021: Efficacy |
Generic approvals (2)
- ANDA213729Novitium Pharma · October 13, 2021
- ANDA213395Navinta LLC · June 22, 2022
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) | 905390, 905394 |
|---|---|
| SPL set ID of the quoted label | 10175e73-5172-4dde-a508-8a88b7afc0a1 |
| FDA labels (SPL) | 4 |
| FDA applications | NDA022562, 2 ANDA |
| Active ingredients (FDA) | CARGLUMIC ACID |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Carbaglu, Recordati Rare Diseases, effective January 25, 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 →