Prescription drug · ANDA
Sapropterin dihydrochloride NDC 72603-194
Sapropterin dihydrochloride 500 mg/1 · Powder, For solution · Oral · NorthStar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-194-30 | 72603019430 | 30 PACKET in 1 CARTON (72603-194-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (72603-194-01)Marketed from Dec 1, 2023 |
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
- NorthStar RxLLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215420
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)Phenylalanine Hydroxylase Activators (Mechanism)
- Identifiers
- Product ID 72603-194_1ccf4222-e182-b467-e063-6394a90a76ecSPL ID 1ccf4222-e182-b467-e063-6394a90a76ecSPL set ID b3999f74-920d-4444-afa7-f4211e4eb431RxCUI 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
N472603019430followed by a unit qualifier and the quantityPackage 72603-0194-30. 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 di…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215420
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Sapropterin dihydrochloride | Sapropterin dihydrochloride 100 mg/1 | Powder, For solutionOral | Camber Pharmaceuticals, Inc. | 31722-047 |
| Sapropterin dihydrochloride | Sapropterin dihydrochloride 500 mg/1 | Powder, For solutionOral | Camber Pharmaceuticals, Inc. | 31722-048 |
| Sapropterin dihydrochloride | Sapropterin dihydrochloride 100 mg/1 | Powder, For solutionOral | NorthStar RxLLC | 72603-193 |