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United States · US · US:50419-171_8f47fb28-9855-4482-b807-e98c425c2a4e
Stivarga
Orange BookUNIISPLATC L01EX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBayer HealthCare Pharmaceuticals Inc.
CountryUS (United States)
ATC codeL01EX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc115041917100210 BOTTLE in 1 BOX (50419-171-00) / 28 TABLET, FILM COATED in 1 BOTTLE
- ndc1150419171033 BOTTLE, PLASTIC in 1 BOX (50419-171-03) / 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-01)
- ndc1150419171041 BOTTLE, PLASTIC in 1 CARTON (50419-171-04) / 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
- ndc1150419171064 BOTTLE, PLASTIC in 1 CARTON (50419-171-06) / 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-05)
Annotations
UNII (FDA Substance ID)
MGN125FS9D
REGORAFENIB
RxCUI 1371319
Orange Book
N203085
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "MGN125FS9D",
"rxcui": "1371319",
"inchikey": "ZOPOQLDXFHBOIH-UHFFFAOYSA-N",
"display_name": "REGORAFENIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"824f19c9-0546-4a8a-8d8f-c4055c04f7c7": {
"match": "brand_token",
"title": "STIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
"spl_version": "36",
"published_date": "2026-02-18"
}
},
"productid": "50419-171_8f47fb28-9855-4482-b807-e98c425c2a4e",
"productndc": "50419-171",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "203085",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "40MG",
"product_no": "001",
"approval_date": "Sep 27, 2012"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "REGORAFENIB",
"proprietary_name": "Stivarga",
"active_ingred_unit": "mg/1",
"application_number": "NDA203085",
"marketing_category": "NDA",
"nonproprietary_name": "regorafenib",
"start_marketing_date": "20120927",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code L01EX05.
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