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United States · US · US:0049-2716_82ce1cc2-6905-465d-9a2a-9f2415af59a0

Cardura

Orange BookUNIISPLATC C02CA04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerROERIG
CountryUS (United States)
ATC codeC02CA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0049271610
    100 TABLET in 1 BOTTLE (0049-2716-10)

Annotations

UNII (FDA Substance ID)
86P6PQK0MU
DOXAZOSIN MESYLATE
RxCUI 39173
Orange Book
N019668
ABABABAB
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": "0049-2716_82ce1cc2-6905-465d-9a2a-9f2415af59a0",
  "productndc": "0049-2716",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "019668",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Nov 2, 1990"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Nov 2, 1990"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "003",
        "approval_date": "Nov 2, 1990"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 8MG BASE",
        "product_no": "004",
        "approval_date": "Nov 2, 1990"
      }
    ],
    "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": "NDA019668",
  "marketing_category": "NDA",
  "nonproprietary_name": "doxazosin",
  "start_marketing_date": "20230215",
  "active_numerator_strength": "8"
}

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