United States· US:0006-5088_8527c7f5-21e5-4965-8b9b-3fe0880a36f3
WINREVAIR
A medicinal product containing sotatercept-csrk, registered in United States by Merck Sharp & Dohme LLC.
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
- SOTATERCEPT-CSRK
- Manufacturer
- Merck Sharp & Dohme LLC
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- June 3, 2026
Packs & prices · 1
- ndc1100065088011 KIT in 1 CARTON (0006-5088-01) * 1 mL in 1 VIAL, SINGLE-DOSE (0006-5069-99) * 1.3 mL in 1 SYRINGE (0006-5080-89)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Sotatercept-csrk in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaWINREVAIRMerck Sharp & Dohme B.V., Haarlem
- BelgiumWinrevair 45 mgMerck Sharp & Dohme
- SwitzerlandWinrevair 45 mg, Pulver und Lösungsmittel zur Herstellung einer InjektionslösungMSD Merck Sharp & Dohme AG
- IcelandWinrevairMerck Sharp & Dohme B.V.*
- SwedenWinrevair 45 mg Pulver och vätska till injektionsvätska, lösningMerck Sharp & Dohme BV
- FinlandWinrevairMerck Sharp & Dohme B.V.
- PolandWinrevairMerck Sharp & Dohme B.V.
- IrelandWinrevair 45 mg powder and solvent for solution for injectionMerck Sharp & Dohme BV,
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Winrevair
- Liechtenstein · Winrevair
- Norway · Winrevair
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/7d1c8796-3eaa-4c0e-83a2-450b618a9a2a GET /v1/drugs/7d1c8796-3eaa-4c0e-83a2-450b618a9a2a?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": null,
"productid": "0006-5088_8527c7f5-21e5-4965-8b9b-3fe0880a36f3",
"productndc": "0006-5088",
"dosage_form": "KIT",
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "WINREVAIR",
"active_ingred_unit": null,
"application_number": "BLA761363",
"marketing_category": "BLA",
"nonproprietary_name": "SOTATERCEPT-CSRK",
"start_marketing_date": "20240326",
"active_numerator_strength": null
}See everything about sotatercept-csrk.
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.