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United States · US · US:57894-201_4d42efb1-d399-2a77-e063-6294a90af3cc
ICOTYDE
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerJanssen Biotech, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1157894201071 BLISTER PACK in 1 CARTON (57894-201-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK (57894-201-01)
- ndc1157894201301 BOTTLE in 1 CARTON (57894-201-30) / 30 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
MUW8FP7HNZ
ICOTROKINRA
Orange Book
N220149
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "MUW8FP7HNZ",
"rxcui": null,
"inchikey": "IVFNYXYPMJQSGF-QMRCQSNESA-N",
"display_name": "ICOTROKINRA",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"aee3c963-edc0-4252-8769-cdf6c7cdc21a": {
"match": "brand_token",
"title": "ICOTYDE (ICOTROKINRA) TABLET, FILM COATED [JANSSEN BIOTECH, INC.]",
"spl_version": "2",
"published_date": "2026-03-19"
}
},
"productid": "57894-201_4d42efb1-d399-2a77-e063-6294a90af3cc",
"productndc": "57894-201",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "220149",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 200MG BASE",
"product_no": "001",
"approval_date": "Mar 17, 2026"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ICOTROKINRA",
"proprietary_name": "ICOTYDE",
"active_ingred_unit": "mg/1",
"application_number": "NDA220149",
"marketing_category": "NDA",
"nonproprietary_name": "icotrokinra",
"start_marketing_date": "20260317",
"active_numerator_strength": "200"
}Access this data programmatically
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