NDC product
Sapropterin Dihydrochloride
NDC 52817-851 · TRUPHARMA, LLC
Key facts
| Product NDC | 52817-851 |
|---|---|
| Proprietary name | Sapropterin Dihydrochloride |
| Nonproprietary name | Sapropterin Dihydrochloride |
| Substances | SAPROPTERIN DIHYDROCHLORIDE |
| Dosage form | POWDER, FOR SOLUTION |
| Route | ORAL |
| Labeler | TRUPHARMA, LLC |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Application number | ANDA216432 |
| Pharmacologic classes | Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA] |
| Marketing start | Jan 30, 2026 |
| Listing certified through | Dec 31, 2027 |
At a glance
- 1–9 Package NDCs
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About National Drug Codes (NDC)
The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.
Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date: