United States· US:59676-575_37a1f6a0-296b-47ee-8060-9e89b01eae72
PREZCOBIX
A medicinal product containing darunavir ethanolate; cobicistat, registered in United States by Janssen Products, LP.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- DARUNAVIR ETHANOLATE; COBICISTAT
- Manufacturer
- Janssen Products, LP
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 1
- ndc1159676-575-30
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Darunavir ethanolate; cobicistat in 3 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaREZOLSTAJanssen-Cilag International N.V., Beerse
- FinlandREZOLSTAJanssen-Cilag International NV
- IrelandREZOLSTA 675 mg/150 mg film-coated tabletsJanssen-Cilag International NV
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Rezolsta
- Liechtenstein · Rezolsta
- Norway · Rezolsta
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/45604817-6a76-4c13-aa98-d83c51672805 GET /v1/drugs/45604817-6a76-4c13-aa98-d83c51672805?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": "800; 150",
"substance": "DARUNAVIR ETHANOLATE; COBICISTAT",
"productndc": "59676-575",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "NDA205395",
"marketing_category": "NDA"
}See everything about darunavir ethanolate; cobicistat.
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.