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United States · US · US:58151-078_7fe31b0a-4fb2-427f-83e2-d5b957d6738b
Cardura
Orange BookUNIISPLATC C02CA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeC02CA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11581510789330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58151-078-93)
Annotations
UNII (FDA Substance ID)
86P6PQK0MU
DOXAZOSIN MESYLATE
RxCUI 39173
Orange Book
N021269
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "86P6PQK0MU",
"rxcui": "39173",
"inchikey": "VJECBOKJABCYMF-UHFFFAOYSA-N",
"display_name": "DOXAZOSIN MESYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"eefc47bc-c10f-49bb-8ef7-5999f798ab39": {
"match": "brand_token",
"title": "CARDURA (DOXAZOSIN MESYLATE) TABLET CARDURA (DOXAZOSIN) TABLET [ROERIG]",
"spl_version": "25",
"published_date": "2026-01-16"
}
},
"productid": "58151-078_7fe31b0a-4fb2-427f-83e2-d5b957d6738b",
"productndc": "58151-078",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "021269",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 4MG BASE",
"product_no": "001",
"approval_date": "Feb 22, 2005"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 8MG BASE",
"product_no": "002",
"approval_date": "Feb 22, 2005"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DOXAZOSIN MESYLATE",
"proprietary_name": "Cardura",
"active_ingred_unit": "mg/1",
"application_number": "NDA021269",
"marketing_category": "NDA",
"nonproprietary_name": "doxazosin mesylate",
"start_marketing_date": "20240423",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code C02CA04.
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