Zelvysia (sapropterin dihydrochloride) NDC 73289-0071

NDC codes

FDA NDC Directory

Product NDC (as listed)73289-0071Labeler and product segments. Claims need a package NDC.

Product NDC at billing width73289-0071Add 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
73289-0071-2	73289007102	30 PACKET in 1 CARTON (73289-0071-2) / 1 POWDER, FOR SOLUTION in 1 PACKET (73289-0071-1)Marketed from Apr 29, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Zelvysia
Generic name (nonproprietary): sapropterin dihydrochloride
Active ingredients: Sapropterin dihydrochloride — 500 mg/1
Dosage form: Powder, For solution
Route: Oral
Labeler: Aucta Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218645
Marketing start: Apr 29, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Breast Cancer Resistance Protein Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)Phenylalanine Hydroxylase Activators (Mechanism)
Identifiers: Product ID 73289-0071_34007201-2d47-96fd-e063-6394a90a6327SPL ID 34007201-2d47-96fd-e063-6394a90a6327SPL set ID 8de84882-dd24-46f2-8416-5e492d4275d1RxCUI 1111018, 1653217, 2712689, 2712691UNII 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

N473289007102 followed by a unit qualifier and the quantity

Package 73289-0071-02. 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 Apr 30, 2025.

Indications (excerpt from the label)

Zelvysia 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). Zelvysia is to be used in conjunction with a Phe-restricted diet. Zelvysia 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). Zelvysia is to be used in conjunction with a Phe‑restricted diet. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 218645

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

FDA NDC Directory listings under ANDA 218645
Product	Strength	Form · route	Labeler	Product NDC
Zelvysiasapropterin dihydrochloride	Sapropterin dihydrochloride 100 mg/1	Powder, For solutionOral	Aucta Pharmaceuticals, Inc.	73289-0070