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United States · US · US:72485-217_35e3a161-752e-4479-b27c-3dc8efd3ca9e
Erlotinib
Orange BookUNIISPLATC L01EB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerArmas Pharmaceuticals Inc.
CountryUS (United States)
ATC codeL01EB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172485217301 BOTTLE in 1 BOX (72485-217-30) / 30 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
DA87705X9K
ERLOTINIB HYDROCHLORIDE
RxCUI 477320
Orange Book
A211960
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": "72485-217_35e3a161-752e-4479-b27c-3dc8efd3ca9e",
"productndc": "72485-217",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "211960",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "Nov 5, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "002",
"approval_date": "Nov 5, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 150MG BASE",
"product_no": "003",
"approval_date": "Nov 5, 2019"
}
],
"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": "ANDA211960",
"marketing_category": "ANDA",
"nonproprietary_name": "Erlotinib hydrochloride",
"start_marketing_date": "20191106",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code L01EB02.
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