Active ingredient
Carglumic Acid
4 finished FDA listings contain Carglumic Acid as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CARGLUMIC ACID
- Dosage forms
- Tablet, For Suspension
- Routes
- Oral
- Manufacturers / labelers
- 4
- Strengths listed
- 200 mg/1
- Brand names in FDA listings
- Carbaglu
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 401713
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 022562 | RECORDATI RARE | 2010-03-18 | 1 |
| ANDA 213729 | NOVITIUM PHARMA | 2021-10-13 | 1 |
| ANDA 213395 | NAVINTA LLC | 2022-06-22 | 2 |
Official labeling on DailyMed
- CARGLUMIC ACID TABLET, FOR SUSPENSION [ETON PHARMACEUTICALS, INC.] · version 4 · 2026-03-05
- CARGLUMIC ACID TABLET, FOR SUSPENSION [NAVINTA LLC] · version 3 · 2024-04-26
- CARGLUMIC ACID TABLET, FOR SUSPENSION [BUREL PHARMACEUTICALS, LLC] · version 2 · 2024-03-29
- CARBAGLU (CARGLUMIC ACID) TABLET, FOR SUSPENSION [RECORDATI RARE DISEASES] · version 36 · 2024-01-31
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.