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United States · US · US:50419-489_e597a26e-e04a-4f91-8c7c-a83243286396
Nexavar
Orange BookUNIISPLATC L01EX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBayer HealthCare Pharmaceuticals Inc.
CountryUS (United States)
ATC codeL01EX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115041948901120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-489-01)
Annotations
UNII (FDA Substance ID)
9ZOQ3TZI87
SORAFENIB
RxCUI 495881
Orange Book
N021923
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9ZOQ3TZI87",
"rxcui": "495881",
"inchikey": "MLDQJTXFUGDVEO-UHFFFAOYSA-N",
"display_name": "SORAFENIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"b50667e4-5ebc-4968-a646-d605058dbef0": {
"match": "brand_token",
"title": "NEXAVAR (SORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
"spl_version": "40",
"published_date": "2024-11-18"
}
},
"productid": "50419-489_e597a26e-e04a-4f91-8c7c-a83243286396",
"productndc": "50419-489",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "021923",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 200MG BASE",
"product_no": "001",
"approval_date": "Dec 20, 2005"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SORAFENIB",
"proprietary_name": "Nexavar",
"active_ingred_unit": "mg/1",
"application_number": "NDA021923",
"marketing_category": "NDA",
"nonproprietary_name": "sorafenib",
"start_marketing_date": "20231002",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code L01EX02.
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