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United States · US · US:0069-0197_cf672c83-c9d9-4107-bcf1-76d4106537cc
Vizimpro
Orange BookUNIISPLATC L01EB07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPfizer Laboratories Div Pfizer Inc
CountryUS (United States)
ATC codeL01EB07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11006901973030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0069-0197-30)
Annotations
UNII (FDA Substance ID)
5092U85G58
DACOMITINIB
RxCUI 2058849
Orange Book
N211288
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5092U85G58",
"rxcui": "2058849",
"inchikey": "BSPLGGCPNTZPIH-IPZCTEOASA-N",
"display_name": "DACOMITINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"4ab27d2f-e385-4e9c-b324-fa69c10b855a": {
"match": "brand_token",
"title": "VIZIMPRO (DACOMITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]",
"spl_version": "8",
"published_date": "2025-12-19"
}
},
"productid": "0069-0197_cf672c83-c9d9-4107-bcf1-76d4106537cc",
"productndc": "0069-0197",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "211288",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "15MG",
"product_no": "001",
"approval_date": "Sep 27, 2018"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "30MG",
"product_no": "002",
"approval_date": "Sep 27, 2018"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "45MG",
"product_no": "003",
"approval_date": "Sep 27, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DACOMITINIB",
"proprietary_name": "Vizimpro",
"active_ingred_unit": "mg/1",
"application_number": "NDA211288",
"marketing_category": "NDA",
"nonproprietary_name": "dacomitinib",
"start_marketing_date": "20181004",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code L01EB07.
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