United States· US:0310-3200_7c42c928-30f8-44ac-a040-d3087b2d6074
ANDEXXA
A andexanet alfa product containing andexanet alfa, registered in United States by AstraZeneca Pharmaceuticals LP. The same ATC class is registered in 12 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Andexanet alfa is registered in 12 of 19 countries.
Countries holding a registration under ATC V03AB38 (andexanet alfa), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 7 of them publish a price we can compare per daily dose
Andexanet alfa · ATC V03AB38
12 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- ANDEXANET ALFA
- Manufacturer
- AstraZeneca Pharmaceuticals LP
- Country
- United States (US)
- ATC code
- V03AB38
- ATC class
- Andexanet alfa
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 4
- ndc1103103200044 VIAL, SINGLE-USE in 1 CARTON (0310-3200-04) / 20 mL in 1 VIAL, SINGLE-USE (0310-3200-01)
- ndc1103103200055 VIAL, SINGLE-USE in 1 CARTON (0310-3200-05) / 20 mL in 1 VIAL, SINGLE-USE (0310-3200-01)
- ndc110310-3200-04
- ndc110310-3200-05
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Andexanet alfa in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaONDEXXYAAstraZeneca AB, Södertälje
- SwitzerlandOndexxya 200 mg, Pulver zur Herstellung einer InfusionslösungAstraZeneca AG
- SpainONDEXXYA 200 MG POLVO PARA SOLUCION PARA PERFUSIONAstrazeneca Ab
- FinlandOndexxyaAstraZeneca AB
- United KingdomOndexxya 200mg powder for solution for infusion vialsAstraZeneca UK Ltd
- IrelandOndexxya Powder for solution for infusionAstraZeneca AB
- IcelandOndexxyaAstraZeneca AB*
- Japanアンデキサネット アルファ（遺伝子組換え）アストラゼネカ
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Ondexxya
- Liechtenstein · Ondexxya
- Norway · Ondexxya
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/44ca3c21-703e-4546-a96e-d7d899a79d74 GET /v1/drugs/44ca3c21-703e-4546-a96e-d7d899a79d74?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": "INTRAVENOUS",
"source": "ndc",
"strength": "200",
"substance": "ANDEXANET ALFA",
"productndc": "0310-3200",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"dea_schedule": null,
"strength_unit": "mg/20mL",
"application_number": "BLA125586",
"marketing_category": "BLA"
}See everything about andexanet alfa.
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.