| NDC Code | 52817-850-30 |
| Package Description | 30 POWDER, FOR SOLUTION in 1 CARTON (52817-850-30) |
| Product NDC | 52817-850 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Sapropterin Dihydrochloride |
| Non-Proprietary Name | Sapropterin Dihydrochloride |
| Dosage Form | POWDER, FOR SOLUTION |
| Usage | ORAL |
| Start Marketing Date | 20240130 |
| Marketing Category Name | ANDA |
| Application Number | ANDA216432 |
| Manufacturer | TRUPHARMA, LLC |
| Substance Name | SAPROPTERIN DIHYDROCHLORIDE |
| Strength | 100 |
| Strength Unit | mg/1 |
| Pharmacy Classes | Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA] |