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United States · US · US:59651-532_3ecafc1e-979a-4aff-a276-18fc0b110491
Erlotinib
Orange BookUNIISPLATC L01EB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeL01EB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11596515320330 TABLET, FILM COATED in 1 BOTTLE (59651-532-03)
- ndc1159651532101 BLISTER PACK in 1 CARTON (59651-532-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
DA87705X9K
ERLOTINIB HYDROCHLORIDE
RxCUI 477320
Orange Book
A216342
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": "59651-532_3ecafc1e-979a-4aff-a276-18fc0b110491",
"productndc": "59651-532",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "216342",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "Jun 22, 2022"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 100MG BASE",
"product_no": "002",
"approval_date": "Jun 22, 2022"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 150MG BASE",
"product_no": "003",
"approval_date": "Jun 22, 2022"
}
],
"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": "ANDA216342",
"marketing_category": "ANDA",
"nonproprietary_name": "Erlotinib",
"start_marketing_date": "20220622",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code L01EB02.
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