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United States · US · US:0310-1349_d703b5ed-4b1c-44fe-8005-ebe3d8f563e6
TAGRISSO
Orange BookUNIISPLATC L01EB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAstraZeneca Pharmaceuticals LP
CountryUS (United States)
ATC codeL01EB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11031013493030 TABLET, FILM COATED in 1 BOTTLE (0310-1349-30)
Annotations
UNII (FDA Substance ID)
3C06JJ0Z2O
OSIMERTINIB
RxCUI 1721560
Orange Book
N208065
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "3C06JJ0Z2O",
"rxcui": "1721560",
"inchikey": "DUYJMQONPNNFPI-UHFFFAOYSA-N",
"display_name": "OSIMERTINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"5e81b4a7-b971-45e1-9c31-29cea8c87ce7": {
"match": "brand_token",
"title": "TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]",
"spl_version": "36",
"published_date": "2026-04-22"
}
},
"productid": "0310-1349_d703b5ed-4b1c-44fe-8005-ebe3d8f563e6",
"productndc": "0310-1349",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "208065",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 40MG BASE",
"product_no": "001",
"approval_date": "Nov 13, 2015"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 80MG BASE",
"product_no": "002",
"approval_date": "Nov 13, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OSIMERTINIB",
"proprietary_name": "TAGRISSO",
"active_ingred_unit": "mg/1",
"application_number": "NDA208065",
"marketing_category": "NDA",
"nonproprietary_name": "osimertinib",
"start_marketing_date": "20151113",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code L01EB04.
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