Prescription drug · NDA
Sephience (sepiapterin) NDC 60468-006
Sepiapterin 1000 mg/1 · Powder · Oral · allphamed Pharbil Arzneimittel GmbH
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60468-006-03 | 60468000603 | 30 PACKET in 1 CARTON (60468-006-03) / 1 POWDER in 1 PACKET (60468-006-01)Marketed from Jul 28, 2025 |
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)
- Sephience
- Generic name (nonproprietary)
- sepiapterin
- Active ingredients
- Sepiapterin — 1000 mg/1
- Dosage form
- Powder
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219666
- Marketing start
- Listing expires
- Identifiers
- Product ID 60468-006_4031b751-a798-3024-e063-6294a90ac2b4SPL ID 4031b751-a798-3024-e063-6294a90ac2b4SPL set ID 9fabfee2-9488-4d03-b203-8fa50f9a7f55RxCUI 2723061, 2723067, 2723069, 2723071UNII CJQ26KO7HPUPC 0352856201033
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
N460468000603followed by a unit qualifier and the quantityPackage 60468-0006-03. 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)
SEPHIENCE is indicated for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive phenylketonuria (PKU). SEPHIENCE is to be used in conjunction with a phenylalanine (Phe)-restricted diet. SEPHIENCE is a phenylalanine hydroxylase (PAH) activator indicated for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive phenylketonuria (PKU). SEPHIENCE is to be used in conjunction with a phenylalanine (Phe)- restricted diet. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 219666
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 |
|---|---|---|---|---|
| Sephiencesepiapterin | Sepiapterin 250 mg/1 | PowderOral | PTC Therapeutics Inc. | 52856-201 |
| Sephiencesepiapterin | Sepiapterin 1000 mg/1 | PowderOral | PTC Therapeutics Inc. | 52856-301 |
| Sephiencesepiapterin | Sepiapterin 250 mg/1 | PowderOral | allphamed Pharbil Arzneimittel GmbH | 60468-007 |