🇺🇸
United States · US · US:50474-350_433f8057-35f8-f7e8-e063-6294a90a3ffd
KYGEVVI
Orange BookUNIISPLATC A16AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUCB, Inc.
CountryUS (United States)
ATC codeA16AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11504743503030 PACKET in 1 CARTON (50474-350-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (50474-350-01)
Annotations
UNII (FDA Substance ID)
0W860991D6
DOXECITINE
Orange Book
N219792
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0W860991D6",
"rxcui": null,
"inchikey": "CKTSBUTUHBMZGZ-SHYZEUOFSA-N",
"display_name": "DOXECITINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"7d5ce670-9314-4fd7-8b0a-1447910dcf9e": {
"match": "brand_token",
"title": "KYGEVVI (DOXECITINE AND DOXRIBTIMINE) POWDER, FOR SOLUTION [UCB, INC.]",
"spl_version": "3",
"published_date": "2026-03-02"
}
},
"productid": "50474-350_433f8057-35f8-f7e8-e063-6294a90a3ffd",
"productndc": "50474-350",
"dosage_form": "POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "219792",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "2GM/PACKET;2GM/PACKET",
"product_no": "001",
"approval_date": "Nov 3, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DOXECITINE; DOXRIBTIMINE",
"proprietary_name": "KYGEVVI",
"active_ingred_unit": "g/1; g/1",
"application_number": "NDA219792",
"marketing_category": "NDA",
"nonproprietary_name": "doxecitine and doxribtimine",
"start_marketing_date": "20260301",
"active_numerator_strength": "2; 2"
}Related drugs
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