| NDC Code | 70710-1926-1 |
| Package Description | 1 VIAL in 1 CARTON (70710-1926-1) / 20 mL in 1 VIAL |
| Product NDC | 70710-1926 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Sodium Phenylacetate And Sodium Benzoate |
| Non-Proprietary Name | Sodium Phenylacetate And Sodium Benzoate |
| Dosage Form | INJECTION, SOLUTION, CONCENTRATE |
| Usage | INTRAVENOUS |
| Start Marketing Date | 20230919 |
| Marketing Category Name | ANDA |
| Application Number | ANDA217526 |
| Manufacturer | Zydus Pharmaceuticals USA Inc. |
| Substance Name | SODIUM BENZOATE; SODIUM PHENYLACETATE |
| Strength | 100; 100 |
| Strength Unit | mg/mL; mg/mL |
| Pharmacy Classes | Ammonium Ion Binding Activity [MoA], Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC], Nitrogen Binding Agent [EPC] |