United States· US:0173-0909_93e60116-b3f2-4568-ae12-03d6e016a953
ZEJULA
A niraparib product containing niraparib tosylate, registered in United States by GlaxoSmithKline LLC. The same ATC class is registered in 14 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Niraparib is registered in 14 of 19 countries.
Countries holding a registration under ATC L01XK02 (niraparib), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 8 of them publish a price we can compare per daily dose
Niraparib · ATC L01XK02
14 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of niraparib costs, country by country.
Normalised to the WHO defined daily dose (0.3 g), so markets compare like for like.
- 1 market with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
Niraparib · price per daily dose (0.3 g)
USD · FX 28 Sept 2026
- CH Switzerland$276.18
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- NIRAPARIB TOSYLATE
- Manufacturer
- GlaxoSmithKline LLC
- Country
- United States (US)
- ATC code
- L01XK02
- ATC class
- Niraparib
- Defined daily dose
- 0.3 g, O
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- August 2, 2026
Packs & prices · 2
- ndc11017309091330 TABLET, FILM COATED in 1 BOTTLE (0173-0909-13)
- ndc110173-0909-13
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
405 interactions on record for niraparib.
Graded by severity as the source publishes them — 29 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
Niraparib · interactions on record
405 records
- 29 severe
- 376 moderate
Most severe, free to view
- CladribineL01BB04severe
- RolapitantA04AD14moderate
- LonafarnibA16AX20moderate
- DicoumarolB01AA01moderate
- 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
Niraparib in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaZEJULAGlaxoSmithKline Trading Services Limited, Dublin
- SpainZEJULA 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULAGlaxosmithkline Trading Services Limited
- SwitzerlandZejula 100 mg, FilmtablettenGlaxoSmithKline AG
- BelgiumAkeega 100 mg - 500 mgJanssen-Cilag International
- NetherlandsZejula 100 mg, filmomhulde tabletGlaxoSmithKline Trading Services Limited
- NorwayZejulaGlaxoSmithKline Trading Services Limited
- PolandZejulaGlaxoSmithKline (Ireland) Limited
- SwedenZejula 100 mg Filmdragerad tablettGlaxoSmithKline Trading Services Ltd
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Zejula
- Liechtenstein · Zejula
- Norway · Zejula
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/cae84201-6ce7-4a2d-aaa1-7e31a37b112d GET /v1/drugs/cae84201-6ce7-4a2d-aaa1-7e31a37b112d?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": "NIRAPARIB TOSYLATE",
"productndc": "0173-0909",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA214876",
"marketing_category": "NDA"
}See everything about niraparib.
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.