United States· US:60923-363_97565339-f295-43ab-98a9-bb6bdf2d049c
Exondys 51
A eteplirsen product containing eteplirsen, registered in United States by Sarepta Therapeutics, Inc.. The same ATC class is registered in 3 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Eteplirsen is registered in 3 of 19 countries.
Countries holding a registration under ATC M09AX06 (eteplirsen), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 2 of them publish a price we can compare per daily dose
Eteplirsen · ATC M09AX06
3 / 19 countries
- Czechiaprice
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- ETEPLIRSEN
- Manufacturer
- Sarepta Therapeutics, Inc.
- Country
- United States (US)
- ATC code
- M09AX06
- ATC class
- Eteplirsen
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1160923-363-02
- ndc1160923363021 VIAL, SINGLE-USE in 1 CARTON (60923-363-02) / 2 mL in 1 VIAL, SINGLE-USE
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Eteplirsen in 2 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
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/ab58be9c-ec70-428a-9335-678800026bfc GET /v1/drugs/ab58be9c-ec70-428a-9335-678800026bfc?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": "50",
"substance": "ETEPLIRSEN",
"productndc": "60923-363",
"dosage_form": "INJECTION",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "NDA206488",
"marketing_category": "NDA"
}See everything about eteplirsen.
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.