Sapropterin Dihydrochloride NDC 42571-510

NDC codes

FDA NDC Directory

Product NDC (as listed)42571-510Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42571-0510Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
42571-510-41	42571051041	30 PACKET in 1 CARTON (42571-510-41) / 1 POWDER, FOR SOLUTION in 1 PACKET (42571-510-60)Marketed from Apr 1, 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 — 500 mg/1
Dosage form: Powder, For solution
Route: Oral
Labeler: Micro Labs Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219511
Marketing start: Apr 1, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Breast Cancer Resistance Protein Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)Phenylalanine Hydroxylase Activators (Mechanism)
Identifiers: Product ID 42571-510_4853076d-14bd-87db-e063-6294a90aad9eSPL ID 4853076d-14bd-87db-e063-6294a90aad9eSPL set ID 907e24c4-3337-4aee-b789-276e37a85cd8RxCUI 1111018, 1653217UNII RG277LF5B3UPC 0342571509415
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

N442571051041 followed by a unit qualifier and the quantity

Package 42571-0510-41. 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 Jan 14, 2026.

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 d…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 219511

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 219511
Product	Strength	Form · route	Labeler	Product NDC
Sapropterin Dihydrochloride	Sapropterin dihydrochloride 100 mg/1	Powder, For solutionOral	Micro Labs Limited	42571-509