Prescription drug · ANDA
Zelvysia (Sapropterin dihydrochloride) NDC 73289-0070
Sapropterin dihydrochloride 100 mg/1 · Powder, For solution · Oral · Aucta Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73289-0070-2 | 7328900700273289007002 | 30 PACKET in 1 CARTON (73289-0070-2) / 1 POWDER, FOR SOLUTION in 1 PACKET (73289-0070-1)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 — 100 mg/1
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Aucta Pharmaceuticals, Inc.NDC labeler code 73289
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218645
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)Phenylalanine Hydroxylase Activators (Mechanism)
- Identifiers
- Product ID 73289-0070_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
N473289007002followed by a unit qualifier and the quantityPackage 73289-0070-02. 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 .
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.
About NDC 73289-0070
- What is NDC 73289-0070?
- 73289-0070 is the product NDC for Zelvysia (sapropterin dihydrochloride), Sapropterin dihydrochloride 100 mg/1 powder, for solution, listed with the FDA by Aucta Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zelvysia (Sapropterin dihydrochloride).
- What is the active ingredient?
- Sapropterin dihydrochloride.
- Who is the labeler?
- Aucta Pharmaceuticals, Inc., NDC labeler code 73289. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zelvysia?
- 1 other product NDC are listed under this name. See all Zelvysia NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zelvysia products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zelvysiasapropterin dihydrochloride | Sapropterin dihydrochloride 500 mg/1 | Powder, For solutionOral | Aucta Pharmaceuticals, Inc. | 73289-0071 | 73289-0071-02 |
Other NDCs under ANDA 218645
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Zelvysiasapropterin dihydrochloride | Sapropterin dihydrochloride 500 mg/1 | Powder, For solutionOral | Aucta Pharmaceuticals, Inc. | 73289-0071 |