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United States · US · US:67184-0531_8aa73f33-2813-4dfa-939f-e4291081449a
Gefitinib
Orange BookUNIISPLATC L01EB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerQilu Pharmaceutical Co., Ltd.
CountryUS (United States)
ATC codeL01EB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11671840531130 TABLET, COATED in 1 BOTTLE (67184-0531-1)
- ndc116718405312500 TABLET, COATED in 1 BOTTLE (67184-0531-2)
- ndc1167184053133 BLISTER PACK in 1 CARTON (67184-0531-3) / 10 TABLET, COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
S65743JHBS
GEFITINIB
RxCUI 328134
Orange Book
A211591
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": "67184-0531_8aa73f33-2813-4dfa-939f-e4291081449a",
"productndc": "67184-0531",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "211591",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Feb 13, 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": "ANDA211591",
"marketing_category": "ANDA",
"nonproprietary_name": "Gefitinib",
"start_marketing_date": "20230213",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code L01EB01.
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- DKGefitinib "Accord"Accord Healthcare B.V.
- DKGefitinib "Mylan"Mylan Pharmaceuticals Limited
- DKGefitinib "Stada"STADA Arzneimittel AG
- GBGefitinib 250mg tabletsGenus Pharmaceuticals Ltd
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