What is NDC 42571-509?

42571-509 is the product NDC for Sapropterin Dihydrochloride, Sapropterin dihydrochloride 100 mg/1 powder, for solution, listed with the FDA by Micro Labs Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Micro Labs Limited, NDC labeler code 42571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Sapropterin Dihydrochloride?

14 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sapropterin Dihydrochloride NDC 42571-509

NDC codes

FDA NDC Directory

Product NDC (as listed)42571-509Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42571-0509Add 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
42571-509-41	4257105094142571050941	30 PACKET in 1 CARTON (42571-509-41) / 1 POWDER, FOR SOLUTION in 1 PACKET (42571-509-30)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 — 100 mg/1
Dosage form: Powder, For solution
Route: Oral
Labeler: Micro Labs LimitedNDC labeler code 42571
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 42571-509_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

N442571050941 followed by a unit qualifier and the quantity

Package 42571-0509-41. 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)

About NDC 42571-509

What is NDC 42571-509?: 42571-509 is the product NDC for Sapropterin Dihydrochloride, Sapropterin dihydrochloride 100 mg/1 powder, for solution, listed with the FDA by Micro Labs Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sapropterin Dihydrochloride.
What is the active ingredient?: Sapropterin dihydrochloride.
Who is the labeler?: Micro Labs Limited, NDC labeler code 42571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sapropterin Dihydrochloride?: 14 other product NDCs are listed under this name. See all Sapropterin Dihydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Sapropterin Dihydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sapropterin Dihydrochloride	Sapropterin dihydrochloride 500 mg/1	Powder, For solutionOral	Micro Labs Limited	42571-510	42571-0510-41
Sapropterin Dihydrochloride	Sapropterin dihydrochloride 100 mg/1	Powder, For solutionOral	TRUPHARMA, LLC	52817-850	52817-0850-0152817-0850-30
Sapropterin Dihydrochloride	Sapropterin dihydrochloride 500 mg/1	Powder, For solutionOral	TRUPHARMA, LLC	52817-851	52817-0851-0152817-0851-30
sapropterin dihydrochloride	Sapropterin dihydrochloride 100 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0906	00054-0906-23
Sapropterin Dihydrochloride	Sapropterin dihydrochloride 100 mg/1	TabletOral	Aurobindo Pharma Limited	59651-574	59651-0574-0859651-0574-2459651-0574-30
sapropterin dihydrochloride	Sapropterin dihydrochloride 100 mg/1	TabletOral	NorthStar RxLLC	72603-191	72603-0191-01
Sapropterin dihydrochloride	Sapropterin dihydrochloride 100 mg/1	Powder, For solutionOral	NorthStar RxLLC	72603-193	72603-0193-30
Sapropterin dihydrochloride	Sapropterin dihydrochloride 500 mg/1	Powder, For solutionOral	NorthStar RxLLC	72603-194	72603-0194-30
sapropterin dihydrochloride	Sapropterin dihydrochloride 100 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-045	31722-0045-12
Sapropterin dihydrochloride	Sapropterin dihydrochloride 100 mg/1	Powder, For solutionOral	Camber Pharmaceuticals, Inc.	31722-047	31722-0047-3031722-0047-31

All 15 Sapropterin Dihydrochloride NDCs

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 500 mg/1	Powder, For solutionOral	Micro Labs Limited	42571-510