NDC product
Carglumic acid
NDC 35573-459 · Burel Pharmaceuticals, LLC
Key facts
| Product NDC | 35573-459 |
|---|---|
| Proprietary name | Carglumic acid |
| Nonproprietary name | Carglumic acid |
| Substances | CARGLUMIC ACID |
| Dosage form | TABLET, FOR SUSPENSION |
| Route | ORAL |
| Labeler | Burel Pharmaceuticals, LLC |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Application number | ANDA213395 |
| Pharmacologic classes | Carbamoyl Phosphate Synthetase 1 Activator [EPC], Carbamoyl Phosphate Synthetase 1 Activators [MoA] |
| Marketing start | Dec 19, 2022 |
| Listing certified through | Dec 31, 2026 |
At a glance
- 1–9 Package NDCs
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About National Drug Codes (NDC)
The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.
Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date: