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United States · US · US:60505-3816_ec5a2f19-c89e-c4cd-c819-a22c585d18b4
Dasatinib
Orange BookUNIISPLATC L01EA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp.
CountryUS (United States)
ATC codeL01EA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11605053816330 TABLET, FILM COATED in 1 BOTTLE (60505-3816-3)
Annotations
UNII (FDA Substance ID)
RBZ1571X5H
DASATINIB
RxCUI 475342
Orange Book
A203180
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "RBZ1571X5H",
"rxcui": "475342",
"inchikey": "XHXFZZNHDVTMLI-UHFFFAOYSA-N",
"display_name": "DASATINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"f9b79d54-9bee-4c93-9c87-f3e65d91f146": {
"match": "brand_token",
"title": "DASATINIB TABLET, FILM COATED [NORTHSTAR RXLLC]",
"spl_version": "2",
"published_date": "2026-06-02"
}
},
"productid": "60505-3816_ec5a2f19-c89e-c4cd-c819-a22c585d18b4",
"productndc": "60505-3816",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "203180",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "80MG",
"product_no": "001",
"approval_date": "Nov 23, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "140MG",
"product_no": "002",
"approval_date": "Nov 23, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DASATINIB",
"proprietary_name": "Dasatinib",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203180",
"marketing_category": "ANDA",
"nonproprietary_name": "Dasatinib",
"start_marketing_date": "20240903",
"active_numerator_strength": "80"
}Related drugs
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