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United States · US · US:0078-0682_6c546993-1f7f-409b-b108-60f22e9b948a
Tafinlar
Orange BookUNIISPLATC L01EC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeL01EC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110078068266120 CAPSULE in 1 BOTTLE (0078-0682-66)
Annotations
UNII (FDA Substance ID)
B6DC89I63E
DABRAFENIB MESYLATE
RxCUI 1425222
Orange Book
N202806
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "B6DC89I63E",
"rxcui": "1425222",
"inchikey": "YKGMKSIHIVVYKY-UHFFFAOYSA-N",
"display_name": "DABRAFENIB MESYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea": {
"match": "brand_token",
"title": "TAFINLAR (DABRAFENIB) CAPSULE TAFINLAR (DABRAFENIB) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]",
"spl_version": "37",
"published_date": "2026-05-21"
}
},
"productid": "0078-0682_6c546993-1f7f-409b-b108-60f22e9b948a",
"productndc": "0078-0682",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "202806",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 50MG BASE",
"product_no": "001",
"approval_date": "May 29, 2013"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 75MG BASE",
"product_no": "002",
"approval_date": "May 29, 2013"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DABRAFENIB MESYLATE",
"proprietary_name": "Tafinlar",
"active_ingred_unit": "mg/1",
"application_number": "NDA202806",
"marketing_category": "NDA",
"nonproprietary_name": "dabrafenib",
"start_marketing_date": "20160412",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code L01EC02.
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