United States· US:43068-304_3248eef5-6bad-4844-a6f9-2f5fddd39c8d
Hetlioz
A tasimelteon product containing tasimelteon, registered in United States by Vanda Pharmaceuticals 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
Tasimelteon is registered in 9 of 19 countries.
Countries holding a registration under ATC N05CH03 (tasimelteon), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 6 of them publish a price we can compare per daily dose
Tasimelteon · ATC N05CH03
9 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Polandprice
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- TASIMELTEON
- Manufacturer
- Vanda Pharmaceuticals Inc.
- Country
- United States (US)
- ATC code
- N05CH03
- ATC class
- Tasimelteon
- Defined daily dose
- 20 mg, O
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- August 2, 2026
Packs & prices · 4
- ndc1143068304021 BOTTLE in 1 CARTON (43068-304-02) / 48 mL in 1 BOTTLE
- ndc1143068304061 BOTTLE in 1 CARTON (43068-304-06) / 158 mL in 1 BOTTLE
- ndc1143068-304-02
- ndc1143068-304-06
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
132 interactions on record for tasimelteon.
Graded by severity as the source publishes them — 7 severe. 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
Tasimelteon · interactions on record
132 records
- 7 severe
- 125 moderate
Most severe, free to view
- MitotaneL01XX23severe
- EnzalutamideL02BB04severe
- ApalutamideL02BB05severe
- MorphineN02AA01severe
- 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.
Same medicine, other countries
Tasimelteon in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaHETLIOZVanda Pharmaceuticals Netherlands B.V., Amsterdam
- FinlandHetliozVanda Pharmaceuticals Netherlands B.V.
- IrelandHETLIOZ 20 mg hard capsulesVanda Pharmaceuticals Netherlands B.V.
- BelgiumHetlioz 20 mgVanda Pharmaceuticals Netherlands
- NetherlandsHetlioz 20 mg harde capsulesVanda Pharmaceuticals Netherlands B.V.
- PolandHetliozVanda Pharmaceuticals Netherlands B.V.
- SwedenHETLIOZ 20 mg Kapsel, hårdVanda Pharmaceuticals Netherlands B.V.
- IcelandHetliozVanda Pharmaceuticals Netherlands B.V.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Hetlioz
- Liechtenstein · Hetlioz
- Norway · Hetlioz
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/e892a487-9a24-4d3a-9211-b6c28da1fcf5 GET /v1/drugs/e892a487-9a24-4d3a-9211-b6c28da1fcf5?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": "4",
"substance": "TASIMELTEON",
"productndc": "43068-304",
"dosage_form": "SUSPENSION",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "NDA214517",
"marketing_category": "NDA"
}See everything about tasimelteon.
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.