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United States · US · US:72205-080_4cff04f5-3693-4d87-a9f8-a2b195e3d26e
Erlotinib Hydrochloride
Orange BookUNIISPLATC L01EB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovadoz Pharmaceuticals LLC
CountryUS (United States)
ATC codeL01EB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172205080301 BOTTLE in 1 CARTON (72205-080-30) / 30 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
DA87705X9K
ERLOTINIB HYDROCHLORIDE
RxCUI 477320
Orange Book
A214366
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": "72205-080_4cff04f5-3693-4d87-a9f8-a2b195e3d26e",
"productndc": "72205-080",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "214366",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "May 10, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "002",
"approval_date": "May 10, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 150MG BASE",
"product_no": "003",
"approval_date": "May 10, 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": "ANDA214366",
"marketing_category": "ANDA",
"nonproprietary_name": "Erlotinib Hydrochloride",
"start_marketing_date": "20210511",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code L01EB02.
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