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United States · US · US:63304-135_c160713b-c06f-49b4-80ea-fc1afb030b81
Erlotinib
Orange BookUNIISPLATC L01EB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeL01EB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1163304135113 BLISTER PACK in 1 CARTON (63304-135-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (63304-135-31)
- ndc11633041353030 TABLET, FILM COATED in 1 BOTTLE (63304-135-30)
Annotations
UNII (FDA Substance ID)
J4T82NDH7E
ERLOTINIB
RxCUI 337525
Orange Book
A210300
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "J4T82NDH7E",
"rxcui": "337525",
"inchikey": "AAKJLRGGTJKAMG-UHFFFAOYSA-N",
"display_name": "ERLOTINIB",
"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": "63304-135_c160713b-c06f-49b4-80ea-fc1afb030b81",
"productndc": "63304-135",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "210300",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "Nov 5, 2019"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 100MG BASE",
"product_no": "002",
"approval_date": "Nov 5, 2019"
},
{
"rs": false,
"rld": false,
"te_code": null,
"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",
"proprietary_name": "Erlotinib",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210300",
"marketing_category": "ANDA",
"nonproprietary_name": "Erlotinib",
"start_marketing_date": "20191105",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code L01EB02.
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