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United States · US · US:0378-1201_40e1cce8-b7c1-4fad-8600-7d7b409bde7e
Sorafenib Tosylate
Orange BookUNIISPLATC L01EX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeL01EX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110378120178120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1201-78)
Annotations
UNII (FDA Substance ID)
5T62Q3B36J
SORAFENIB TOSYLATE
RxCUI 597744
Orange Book
A207012
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5T62Q3B36J",
"rxcui": "597744",
"inchikey": "IVDHYUQIDRJSTI-UHFFFAOYSA-N",
"display_name": "SORAFENIB TOSYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"93f9c3b2-d4c5-80d3-5421-8b4c29fbf8a6": {
"match": "brand_token",
"title": "SORAFENIB TABLET, FILM COATED [DR.REDDYS LABORATORIES INC]",
"spl_version": "7",
"published_date": "2026-05-21"
}
},
"productid": "0378-1201_40e1cce8-b7c1-4fad-8600-7d7b409bde7e",
"productndc": "0378-1201",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "207012",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 200MG BASE",
"product_no": "001",
"approval_date": "Sep 10, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SORAFENIB TOSYLATE",
"proprietary_name": "Sorafenib Tosylate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA207012",
"marketing_category": "ANDA",
"nonproprietary_name": "Sorafenib",
"start_marketing_date": "20220601",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code L01EX02.
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