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United States · US · US:50419-397_654f8e2c-0b86-4320-b392-81f42fa8cadd
HYRNUO
Orange BookUNIISPLATC L01EH
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBayer HealthCare Pharmaceuticals Inc.
CountryUS (United States)
ATC codeL01EH
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115041939701120 TABLET, FILM COATED in 1 BOTTLE (50419-397-01)
Annotations
UNII (FDA Substance ID)
2A7VPM5RWH
SEVABERTINIB
Orange Book
N219972
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2A7VPM5RWH",
"rxcui": null,
"inchikey": "VYQVHWNNPKOJEA-AWEZNQCLSA-N",
"display_name": "SEVABERTINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"d7a11334-6e7a-445b-9a16-bdcd9acbe61f": {
"match": "brand_token",
"title": "HYRNUO (SEVABERTINIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
"spl_version": "8",
"published_date": "2026-03-05"
}
},
"productid": "50419-397_654f8e2c-0b86-4320-b392-81f42fa8cadd",
"productndc": "50419-397",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "219972",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Nov 19, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SEVABERTINIB",
"proprietary_name": "HYRNUO",
"active_ingred_unit": "mg/1",
"application_number": "NDA219972",
"marketing_category": "NDA",
"nonproprietary_name": "SEVABERTINIB",
"start_marketing_date": "20251119",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code L01EH.
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