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United States · US · US:70771-1523_9d253beb-cd1f-45df-9b23-c521269d419f
Erlotinib
Orange BookUNIISPLATC L01EB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeL01EB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11707711523330 TABLET, FILM COATED in 1 BOTTLE (70771-1523-3)
- ndc1170771152373 BLISTER PACK in 1 CARTON (70771-1523-7) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1523-2)
- ndc11707711523990 TABLET, FILM COATED in 1 BOTTLE (70771-1523-9)
Annotations
UNII (FDA Substance ID)
DA87705X9K
ERLOTINIB HYDROCHLORIDE
RxCUI 477320
Orange Book
A213065
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "DA87705X9K",
"rxcui": "477320",
"inchikey": "GTTBEUCJPZQMDZ-UHFFFAOYSA-N",
"display_name": "ERLOTINIB HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"daaa1329-3a3f-439c-b13d-b301daa234d4": {
"match": "brand_token",
"title": "ERLOTINIB TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]",
"spl_version": "3",
"published_date": "2024-12-02"
}
},
"productid": "70771-1523_9d253beb-cd1f-45df-9b23-c521269d419f",
"productndc": "70771-1523",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "213065",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "Apr 16, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "002",
"approval_date": "Apr 16, 2020"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "EQ 150MG BASE",
"product_no": "003",
"approval_date": "Apr 16, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ERLOTINIB HYDROCHLORIDE",
"proprietary_name": "Erlotinib",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213065",
"marketing_category": "ANDA",
"nonproprietary_name": "Erlotinib",
"start_marketing_date": "20200430",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code L01EB02.
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