Sapropterin dihydrochloride NDC 31722-048

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-048Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0048Add 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
31722-048-30	31722004830	30 PACKET in 1 CARTON (31722-048-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-048-01)Marketed from Aug 18, 2022
31722-048-31	31722004831	1 PACKET in 1 CARTON (31722-048-31) / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-048-01)Marketed from Aug 18, 2022

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: Camber Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215420
Marketing start: Aug 18, 2022
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 31722-048_4c45ff1f-15f2-2237-e063-6294a90a0acaSPL ID 4c45ff1f-15f2-2237-e063-6294a90a0acaSPL set ID 3f0d6820-ff59-40c0-882f-aeea2dd1d1adRxCUI 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

N431722004830 followed by a unit qualifier and the quantity

Package 31722-0048-30. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 215420

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

FDA NDC Directory listings under ANDA 215420
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 100 mg/1	Powder, For solutionOral	NorthStar RxLLC	72603-193
Sapropterin dihydrochloride	Sapropterin dihydrochloride 500 mg/1	Powder, For solutionOral	NorthStar RxLLC	72603-194