NDC 35573-459
Carglumic acid
Carglumic Acid
Carglumic acid is a Oral Tablet, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Burel Pharmaceuticals, Llc. The primary component is Carglumic Acid.
| Product ID | 35573-459_5d8ac14d-dd85-4d80-9e3d-07a52e1f72ab |
| NDC | 35573-459 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Carglumic acid |
| Generic Name | Carglumic Acid |
| Dosage Form | Tablet, For Suspension |
| Route of Administration | ORAL |
| Marketing Start Date | 2022-12-19 |
| Marketing Category | ANDA / |
| Application Number | ANDA213395 |
| Labeler Name | Burel Pharmaceuticals, LLC |
| Substance Name | CARGLUMIC ACID |
| Active Ingredient Strength | 200 mg/1 |
| Pharm Classes | Carbamoyl Phosphate Synthetase 1 Activator [EPC], Carbamoyl Phosphate Synthetase 1 Activators [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |