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United States · US · US:46708-567_966e67f7-6259-4b1c-8c6a-b2589d57e1ed
ERLOTINIB HYDROCHLORIDE
Orange BookUNIISPLATC L01EB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeL01EB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11467085673030 TABLET, FILM COATED in 1 BOTTLE (46708-567-30)
- ndc11467085679090 TABLET, FILM COATED in 1 BOTTLE (46708-567-90)
Annotations
UNII (FDA Substance ID)
DA87705X9K
ERLOTINIB HYDROCHLORIDE
RxCUI 477320
Orange Book
A214719
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": "46708-567_966e67f7-6259-4b1c-8c6a-b2589d57e1ed",
"productndc": "46708-567",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "214719",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "Jul 8, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "002",
"approval_date": "Jul 8, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 150MG BASE",
"product_no": "003",
"approval_date": "Jul 8, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ERLOTINIB HYDROCHLORIDE",
"proprietary_name": "ERLOTINIB HYDROCHLORIDE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA214719",
"marketing_category": "ANDA",
"nonproprietary_name": "ERLOTINIB HYDROCHLORIDE",
"start_marketing_date": "20210709",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code L01EB02.
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