🇺🇸
United States · US · US:69339-168_5a5b1155-767f-4e57-bd89-c67c80b40972
Gefitinib
Orange BookUNIISPLATC L01EB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNatco Pharma USA LLC
CountryUS (United States)
ATC codeL01EB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11693391680330 TABLET, FILM COATED in 1 BOTTLE (69339-168-03)
Annotations
UNII (FDA Substance ID)
S65743JHBS
GEFITINIB
RxCUI 328134
Orange Book
A212827
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "S65743JHBS",
"rxcui": "328134",
"inchikey": "XGALLCVXEZPNRQ-UHFFFAOYSA-N",
"display_name": "GEFITINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"1a3c0ce7-06a1-4e04-9106-14ddb2a866a5": {
"match": "brand_token",
"title": "GEFITINIB TABLET, FILM COATED [NATCO PHARMA USA LLC]",
"spl_version": "4",
"published_date": "2026-03-11"
}
},
"productid": "69339-168_5a5b1155-767f-4e57-bd89-c67c80b40972",
"productndc": "69339-168",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "212827",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "May 31, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GEFITINIB",
"proprietary_name": "Gefitinib",
"active_ingred_unit": "mg/1",
"application_number": "ANDA212827",
"marketing_category": "ANDA",
"nonproprietary_name": "Gefitinib",
"start_marketing_date": "20230605",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code L01EB01.
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- 🇺🇸GefitinibTeva Pharmaceuticals, Inc.
- DKGefitinib "Accord"Accord Healthcare B.V.
- DKGefitinib "Mylan"Mylan Pharmaceuticals Limited
- DKGefitinib "Stada"STADA Arzneimittel AG
- GBGefitinib 250mg tabletsViatris UK Healthcare Ltd
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