| NDC Code | 68475-513-01 |
|---|
| Package Description | 1 VIAL in 1 CARTON (68475-513-01) / 20 mL in 1 VIAL |
|---|
| Product NDC | 68475-513 |
|---|
| 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 | 20251206 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA217526 |
|---|
| Manufacturer | Navinta LLC |
|---|
| 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] |
|---|