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United States · US · US:58151-079_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

  • ndc11
    5815107993
    30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58151-079-93)

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": "58151-079_7fe31b0a-4fb2-427f-83e2-d5b957d6738b",
  "productndc": "58151-079",
  "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": "20240104",
  "active_numerator_strength": "8"
}

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