Prescription drug · NDA
Sephience (Sepiapterin) NDC 52856-301
Sepiapterin 1000 mg/1 · Powder · Oral · PTC Therapeutics Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52856-301-03 | 5285603010352856030103 | 30 PACKET in 1 CARTON (52856-301-03) / 1 POWDER in 1 PACKET (52856-301-01)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
- Labeler
- PTC Therapeutics Inc.NDC labeler code 52856
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219666
- Marketing start
- Listing expires
- Identifiers
- Product ID 52856-301_15baff9a-9d66-4546-b209-7a570a2f16c5SPL ID 15baff9a-9d66-4546-b209-7a570a2f16c5SPL set ID 32ac719c-49f0-4105-9c46-18c19583a5c2RxCUI 2723061, 2723067, 2723069, 2723071UNII CJQ26KO7HPUPC 0352856301030, 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
N452856030103followed by a unit qualifier and the quantityPackage 52856-0301-03. 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.
About NDC 52856-301
- What is NDC 52856-301?
- 52856-301 is the product NDC for Sephience (sepiapterin), Sepiapterin 1000 mg/1 powder, listed with the FDA by PTC Therapeutics Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sephience (Sepiapterin).
- What is the active ingredient?
- Sepiapterin.
- Who is the labeler?
- PTC Therapeutics Inc., NDC labeler code 52856. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sephience?
- 3 other product NDCs are listed under this name. See all Sephience NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sephience products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sephiencesepiapterin | Sepiapterin 250 mg/1 | PowderOral | PTC Therapeutics Inc. | 52856-201 | 52856-0201-03 |
| Sephiencesepiapterin | Sepiapterin 1000 mg/1 | PowderOral | allphamed Pharbil Arzneimittel GmbH | 60468-006 | 60468-0006-03 |
| Sephiencesepiapterin | Sepiapterin 250 mg/1 | PowderOral | allphamed Pharbil Arzneimittel GmbH | 60468-007 | 60468-0007-03 |
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 | allphamed Pharbil Arzneimittel GmbH | 60468-006 |
| Sephiencesepiapterin | Sepiapterin 250 mg/1 | PowderOral | allphamed Pharbil Arzneimittel GmbH | 60468-007 |