🇺🇸
United States · US · US:68382-914_e34fafdf-2fda-4031-9202-6d7e85925dc1
Erlotinib
Orange BookUNIISPLATC L01EB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeL01EB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11683829140630 TABLET in 1 BOTTLE (68382-914-06)
- ndc11683829141690 TABLET in 1 BOTTLE (68382-914-16)
- ndc1168382914843 BLISTER PACK in 1 CARTON (68382-914-84) / 10 TABLET in 1 BLISTER PACK (68382-914-30)
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": "68382-914_e34fafdf-2fda-4031-9202-6d7e85925dc1",
"productndc": "68382-914",
"dosage_form": "TABLET",
"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": "100"
}Related drugs
Other records sharing ATC code L01EB02.
Access this data programmatically
Query Erlotinib and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.