United States· US:70564-802_8640ba06-76d4-4855-a1d3-c25220b7366e
MYTESI
A crofelemer product containing crofelemer, registered in United States by Napo Pharmaceuticals, Inc..
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
- CROFELEMER
- Manufacturer
- Napo Pharmaceuticals, Inc.
- Country
- United States (US)
- ATC code
- A07XA06
- ATC class
- Crofelemer
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- August 9, 2026
Packs & prices · 2
- ndc11705648026060 TABLET, COATED in 1 BOTTLE (70564-802-60)
- ndc1170564-802-60
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same class
Other records under A07XA06
Crofelemer, as other registers publish it.
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/bd41a166-589a-4402-9643-1bcf6fa07ed0 GET /v1/drugs/bd41a166-589a-4402-9643-1bcf6fa07ed0?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": "125",
"substance": "CROFELEMER",
"productndc": "70564-802",
"dosage_form": "TABLET, COATED",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA202292",
"marketing_category": "NDA"
}See everything about crofelemer.
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.