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United States · US · US:73362-203_7bc0f18a-5736-4451-8790-f3780b742ab3
Yuviwel
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAscendis Pharma Endocrinology, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1173362203014 BOX in 1 CARTON (73362-203-01) / 1 KIT in 1 BOX (73362-203-02) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (73362-207-01) * 1 SOLUTION in 1 SYRINGE, GLASS (73362-801-01)
Annotations
Orange Book
N219164
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"e01c1197-338f-414c-b804-808e129ebc8c": {
"match": "brand_token",
"title": "YUVIWEL (NAVEPEGRITIDE) KIT [ASCENDIS PHARMA ENDOCRINOLOGY, INC.]",
"spl_version": "4",
"published_date": "2026-03-30"
}
},
"productid": "73362-203_7bc0f18a-5736-4451-8790-f3780b742ab3",
"productndc": "73362-203",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "219164",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1.3MG/VIAL",
"product_no": "001",
"approval_date": "Feb 27, 2026"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "2.8MG/VIAL",
"product_no": "002",
"approval_date": "Feb 27, 2026"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "5.5MG/VIAL",
"product_no": "003",
"approval_date": "Feb 27, 2026"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Yuviwel",
"active_ingred_unit": null,
"application_number": "NDA219164",
"marketing_category": "NDA",
"nonproprietary_name": "Navepegritide",
"start_marketing_date": "20260227",
"active_numerator_strength": null
}Access this data programmatically
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