Doxazosin

Orange BookUNIISPLATC C02CA04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeC02CA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7161078960
90 TABLET in 1 BOTTLE (71610-789-60)

Annotations

UNII (FDA Substance ID)

86P6PQK0MU

DOXAZOSIN MESYLATE

RxCUI 39173

Orange Book

A209013

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": {
    "2ea9bb6b-a4f0-496a-b27b-4454167a4b70": {
      "match": "brand_token",
      "title": "DOXAZOSIN TABLET [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "21",
      "published_date": "2026-05-15"
    }
  },
  "productid": "71610-789_2740bf42-a82a-44fb-9617-a005a5561d64",
  "productndc": "71610-789",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209013",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Apr 17, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Apr 17, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "003",
        "approval_date": "Apr 17, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 8MG BASE",
        "product_no": "004",
        "approval_date": "Apr 17, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DOXAZOSIN MESYLATE",
  "proprietary_name": "Doxazosin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209013",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxazosin Mesylate",
  "start_marketing_date": "20180417",
  "active_numerator_strength": "4"
}

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