United States· US:52817-850_4b1fe6f7-f641-ec9a-e063-6394a90a4e04

Sapropterin Dihydrochloride

A sapropterin product containing sapropterin dihydrochloride, registered in United States by TRUPHARMA, LLC. The same ATC class is registered in 19 of our 19 countries.

ATC A16AX07US label

Checked against FDA National Drug Code directory (United States) on September 27, 2026

Informational only — not a medical device.

Compare price across countriesPer daily dose · free account Ask the assistant about sapropterin dihydrochlorideAnswers with sources · free account Check interactionsSeverity free · mechanism on Growth

Where it is registered

Sapropterin is registered in 19 of 19 countries.

Countries holding a registration under ATC A16AX07 (sapropterin), each read from that country’s own register.

This record: United States, from FDA National Drug Code directory (United States)
11 of them publish a price we can compare per daily dose

Search sapropterin products by name

Sapropterin · ATC A16AX07

19 / 19 countries

Belgiumprice
Canada
Czechiaprice
Denmark
Finlandprice
Franceprice
Germany
Icelandprice
Ireland
Italyprice
Japan
Netherlands
Norwayprice
Polandprice
Spainprice
Sweden
Switzerlandprice
United Kingdom
United Statesprice

Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

Price per daily dose

What a daily dose of sapropterin costs, country by country.

Normalised to the WHO defined daily dose (0.7 g), so markets compare like for like.

2 markets with a comparable price for this class
Public list prices, converted to USD at the rate date shown

Open the full comparison — free account Drug prices for market access

Sapropterin · price per daily dose (0.7 g)

USD · FX 28 Sept 2026

CH Switzerland$159.61
IT Italy$156.69

Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

FDA National Drug Code directory (United States)

Active substance: SAPROPTERIN DIHYDROCHLORIDE
Manufacturer: TRUPHARMA, LLC
Country: United States (US)
ATC code: A16AX07
ATC class: Sapropterin
Defined daily dose: 0.7 g, O
Reimbursed: Not published by this register
Source register: FDA National Drug Code directory (United States)
Last checked: September 27, 2026

Packs & prices · 4

ndc11
52817-850-01
ndc11
52817-850-30
ndc11
5281785001
1 POWDER, FOR SOLUTION in 1 POUCH (52817-850-01)
ndc11
5281785030
30 POWDER, FOR SOLUTION in 1 CARTON (52817-850-30)

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

29 interactions on record for sapropterin.

Graded by severity as the source publishes them — 29 moderate. Severity grades are free for everyone; mechanism and management come with Growth.

Severity for every pair — free, no plan needed
The source, licence and sync date on every record
Mechanism and what to do for each pair — Growth plan

Check sapropterin against other medicines How interaction checks work

Sapropterin · interactions on record

29 records

29 moderate

Most severe, free to view

Glyceryl trinitrateC01DA02moderate
Isosorbide dinitrateC01DA08moderate
Isosorbide mononitrateC01DA14moderate
NesiritideC01DX19moderate

Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.

Mechanism and what to do, in the interaction check

Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Sapropterin in 16 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All sapropterin products

Authorised across Europe · EMA

The same active substance is authorised in 15 EEA countries. Names it is sold under:

Bulgaria · Сапроптерин Тева
Czechia · Sapropterin Piam Farmaceutici
Germany · Arpetran, Sapropterin Al
Denmark · Arpetran, Sapropterin Sandoz
Spain · Sapropterina Aurovitas, Sapropterina Elc
France · Sapropterine Arrow, Sapropterine Teva
United Kingdom (Northern Ireland) · Sapropterin Dihydrochloride, Sapropterin Dihydrochloride Amarox
Iceland · Kuvan, Sapropterin Dipharma
Italy · Arpetran, Sapropterina Aurobindo
Liechtenstein · Kuvan, Sapropterin Dipharma
Malta · Sapropterina Generis
Netherlands · Arpetran, Sapropterin Aurobindo
Norway · Kuvan, Sapropterin Dipharma
Portugal · Arpetran, Sapropterina Generis
Sweden · Sapropterin Stada, Sapropterin Teva

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/f7c7cc01-e8e5-4950-a650-a17146808ecf
GET /v1/drugs/f7c7cc01-e8e5-4950-a650-a17146808ecf?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": "100",
  "substance": "SAPROPTERIN DIHYDROCHLORIDE",
  "productndc": "52817-850",
  "dosage_form": "POWDER, FOR SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA216432",
  "marketing_category": "ANDA"
}

API reference MCP server Plans

See everything about sapropterin.

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.

Try it free Open in the console