Prescription drug · ANDA
Sapropterin Dihydrochloride NDC 49884-873
Sapropterin dihydrochloride 500 mg/1 · Powder, For solution · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49884-873-72 | 49884087372 | 30 PACKET in 1 CARTON (49884-873-72) / 1 POWDER, FOR SOLUTION in 1 PACKET (49884-873-52)Marketed from Oct 1, 2020 |
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 — 500 mg/1
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Par Health USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210027
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)Phenylalanine Hydroxylase Activators (Mechanism)
- Identifiers
- Product ID 49884-873_d9caf600-36bf-443b-bd05-cfeef3d84522SPL ID d9caf600-36bf-443b-bd05-cfeef3d84522SPL set ID 2e13a3b5-e4df-4d5c-9b26-02a7006a7c3eRxCUI 1653217UNII RG277LF5B3UPC 0349884873721
- 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
N449884087372followed by a unit qualifier and the quantityPackage 49884-0873-72. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.