| NDC Code | 68682-001-50 |
| Package Description | 1 VIAL, SINGLE-USE in 1 CARTON (68682-001-50) / 50 mL in 1 VIAL, SINGLE-USE |
| Product NDC | 68682-001 |
| 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 | 20170315 |
| End Marketing Date | 20250331 |
| Marketing Category Name | NDA AUTHORIZED GENERIC |
| Application Number | NDA020645 |
| Manufacturer | Oceanside Pharmaceuticals |
| 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] |