sapropterin dihydrochloride NDC 31722-045

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-045Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0045Add 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
31722-045-12	31722004512	120 TABLET in 1 BOTTLE (31722-045-12)Marketed from Aug 23, 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 — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Camber Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215534
Marketing start: Aug 23, 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 31722-045_4b91366e-4989-50aa-e063-6294a90ac65fSPL ID 4b91366e-4989-50aa-e063-6294a90ac65fSPL set ID ec8ea96c-8ec1-4301-a85d-d59562e548caRxCUI 1486687UNII RG277LF5B3UPC 0331722045124
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

N431722004512 followed by a unit qualifier and the quantity

Package 31722-0045-12. 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 Feb 24, 2026.

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 conjunct…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 215534

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

FDA NDC Directory listings under ANDA 215534
Product	Strength	Form · route	Labeler	Product NDC
sapropterin dihydrochloride	Sapropterin dihydrochloride 100 mg/1	TabletOral	NorthStar RxLLC	72603-191