Prescription drug · ANDA
Sapropterin Dihydrochloride NDC 52817-850
Sapropterin dihydrochloride 100 mg/1 · Powder, For solution · Oral · TRUPHARMA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52817-850-01 | 52817085001 | 1 POWDER, FOR SOLUTION in 1 POUCH (52817-850-01)Marketed from Jan 30, 2026 | |
| 52817-850-30 | 52817085030 | 30 POWDER, FOR SOLUTION in 1 CARTON (52817-850-30)Marketed from Jan 30, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Sapropterin Dihydrochloride
- Generic name (nonproprietary)
- sapropterin dihydrochloride
- Active ingredients
- Sapropterin dihydrochloride — 100 mg/1
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- TRUPHARMA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216432
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)Phenylalanine Hydroxylase Activators (Mechanism)
- Identifiers
- Product ID 52817-850_4b1fe6f7-f641-ec9a-e063-6394a90a4e04SPL ID 4b1fe6f7-f641-ec9a-e063-6394a90a4e04SPL set ID 39f1d020-4359-401b-88a8-ed25eaa40b45RxCUI 1111018, 1653217UNII RG277LF5B3
- Pharmacologic class
- Phenylalanine Hydroxylase Activator
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N452817085001followed by a unit qualifier and the quantityPackage 52817-0850-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Sapropterin dihydrochloride powder for oral solution is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride powder for oral solution is to be used in conjunction with a Phe- restricted diet. Sapropterin dihydrochloride powder for oral solution is a phenylalanine hydroxylase activator indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Sapropterin…
Excerpt only. Read the full label for complete information.