Prescription drug · ANDA
Sapropterin Dihydrochloride NDC 59651-574
Sapropterin dihydrochloride 100 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-574-08 | 59651057408 | 120 TABLET in 1 BOTTLE (59651-574-08)Marketed from Jun 9, 2025 | |
| 59651-574-24 | 59651057424 | 240 TABLET in 1 BOTTLE (59651-574-24)Marketed from Jun 9, 2025 | |
| 59651-574-30 | 59651057430 | 30 TABLET in 1 BOTTLE (59651-574-30)Marketed from Jun 9, 2025 |
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
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216797
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)Phenylalanine Hydroxylase Activators (Mechanism)
- Identifiers
- Product ID 59651-574_11ee25bc-f501-4f9d-b63d-63b2eee0147eSPL ID 11ee25bc-f501-4f9d-b63d-63b2eee0147eSPL set ID 11ee25bc-f501-4f9d-b63d-63b2eee0147eRxCUI 1486687UNII RG277LF5B3UPC 0359651574300
- 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
N459651057408followed by a unit qualifier and the quantityPackage 59651-0574-08. 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 tablets are 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 tablets are to be used in conjunction with a Phe-restricted diet. Sapropterin dihydrochloride tablets are 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 dihydrochloride tablets are to be used in conjun…
Excerpt only. Read the full label for complete information.