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United States · US · US:58468-7840_abb9eb38-c6a9-49e9-8e90-852f95773feb
CAPRELSA
Orange BookUNIISPLATC L01EX04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGenzyme Corporation
CountryUS (United States)
ATC codeL01EX04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1158468784031 BOTTLE, PLASTIC in 1 CARTON (58468-7840-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
YO460OQ37K
VANDETANIB
RxCUI 1098413
Orange Book
N022405
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "YO460OQ37K",
"rxcui": "1098413",
"inchikey": "UHTHHESEBZOYNR-UHFFFAOYSA-N",
"display_name": "VANDETANIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e5721cb8-4185-47b9-bbb3-1c587e558a03": {
"match": "brand_token",
"title": "CAPRELSA (VANDETANIB) TABLET, FILM COATED [GENZYME CORPORATION]",
"spl_version": "14",
"published_date": "2026-04-27"
}
},
"productid": "58468-7840_abb9eb38-c6a9-49e9-8e90-852f95773feb",
"productndc": "58468-7840",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "022405",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "100MG",
"product_no": "001",
"approval_date": "Apr 6, 2011"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "300MG",
"product_no": "002",
"approval_date": "Apr 6, 2011"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VANDETANIB",
"proprietary_name": "CAPRELSA",
"active_ingred_unit": "mg/1",
"application_number": "NDA022405",
"marketing_category": "NDA",
"nonproprietary_name": "Vandetanib",
"start_marketing_date": "20110725",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code L01EX04.
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