🇺🇸
United States · US · US:70564-802_8640ba06-76d4-4855-a1d3-c25220b7366e
MYTESI
Orange BookUNIISPLATC A07XA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNapo Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA07XA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11705648026060 TABLET, COATED in 1 BOTTLE (70564-802-60)
Annotations
UNII (FDA Substance ID)
PY79D6C8RX
CROFELEMER
RxCUI 1364449
Orange Book
N202292
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "PY79D6C8RX",
"rxcui": "1364449",
"inchikey": null,
"display_name": "CROFELEMER",
"substance_type": "polymer",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"45584fba-8081-4cd1-a21e-3ea8237f62ff": {
"match": "brand_token",
"title": "MYTESI (CROFELEMER) TABLET, COATED [NAPO PHARMACEUTICALS, INC.]",
"spl_version": "7",
"published_date": "2025-12-24"
}
},
"productid": "70564-802_8640ba06-76d4-4855-a1d3-c25220b7366e",
"productndc": "70564-802",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "202292",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "125MG",
"product_no": "001",
"approval_date": "Dec 31, 2012"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CROFELEMER",
"proprietary_name": "MYTESI",
"active_ingred_unit": "mg/1",
"application_number": "NDA202292",
"marketing_category": "NDA",
"nonproprietary_name": "Crofelemer",
"start_marketing_date": "20160801",
"active_numerator_strength": "125"
}Access this data programmatically
Query MYTESI and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.