🇺🇸
United States · US · US:0310-0482_508019dd-61d5-4459-9476-3f5897143f0c
IRESSA
Orange BookUNIISPLATC L01EB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAstraZeneca Pharmaceuticals LP
CountryUS (United States)
ATC codeL01EB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11031004823030 TABLET, COATED in 1 BOTTLE (0310-0482-30)
Annotations
UNII (FDA Substance ID)
S65743JHBS
GEFITINIB
RxCUI 328134
Orange Book
N206995
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": {
"827d60e8-7e07-41b7-c28b-49ef1c4a5a41": {
"match": "brand_token",
"title": "IRESSA (GEFITINIB) TABLET, COATED [ASTRAZENECA PHARMACEUTICALS LP]",
"spl_version": "19",
"published_date": "2025-08-18"
}
},
"productid": "0310-0482_508019dd-61d5-4459-9476-3f5897143f0c",
"productndc": "0310-0482",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "206995",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Jul 13, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GEFITINIB",
"proprietary_name": "IRESSA",
"active_ingred_unit": "mg/1",
"application_number": "NDA206995",
"marketing_category": "NDA",
"nonproprietary_name": "Gefitinib",
"start_marketing_date": "20150713",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code L01EB01.
- CAAPO-GEFITINIBAPOTEX INC
- 🇺🇸GefitinibIngenus Pharmaceuticals, LLC
- 🇺🇸GefitinibNatco Pharma USA LLC
- 🇺🇸GefitinibTeva Pharmaceuticals, Inc.
- 🇺🇸GefitinibQilu Pharmaceutical Co., Ltd.
- DKGefitinib "Accord"Accord Healthcare B.V.
- DKGefitinib "Mylan"Mylan Pharmaceuticals Limited
- DKGefitinib "Stada"STADA Arzneimittel AG
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