United States· US:52856-301_15baff9a-9d66-4546-b209-7a570a2f16c5
Sephience
A sepiapterin product containing sepiapterin, registered in United States by PTC Therapeutics Inc.. The same ATC class is registered in 9 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Sepiapterin is registered in 9 of 19 countries.
Countries holding a registration under ATC A16AX28 (sepiapterin), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 5 of them publish a price we can compare per daily dose
Sepiapterin · ATC A16AX28
9 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Franceprice
- Icelandprice
- Ireland
- Japan
- Netherlands
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- SEPIAPTERIN
- Manufacturer
- PTC Therapeutics Inc.
- Country
- United States (US)
- ATC code
- A16AX28
- ATC class
- Sepiapterin
- Defined daily dose
- 4.25 g, O
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc11528563010330 PACKET in 1 CARTON (52856-301-03) / 1 POWDER in 1 PACKET (52856-301-01)
- ndc1152856-301-03
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Sepiapterin in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumSephience 1000 mgPTC Therapeutics International
- SwitzerlandSephience 1000 mg, Pulver zum EinnehmenPTC Therapeutics Switzerland GmbH
- CzechiaSEPHIENCEPTC Therapeutics International Limited, Dublin 2
- SpainSEPHIENCE 1000 MG POLVO ORAL EN SOBREPtc Therapeutics International Limited
- FinlandSephiencePTC Therapeutics International Limited
- IcelandSephiencePTC Therapeutics International Limited
- PolandSephiencePTC Therapeutics International Ltd.
- SwedenSephience 1000 mg Oralt pulver i dospåsePTC Therapeutics International Limited
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Sephience
- Liechtenstein · Sephience
- Norway · Sephience
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/c67bc79f-77df-4a72-b8aa-b2ecf432d281 GET /v1/drugs/c67bc79f-77df-4a72-b8aa-b2ecf432d281?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "ORAL",
"source": "ndc",
"strength": "1000",
"substance": "SEPIAPTERIN",
"productndc": "52856-301",
"dosage_form": "POWDER",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA219666",
"marketing_category": "NDA"
}See everything about sepiapterin.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.