Back to search
🇺🇸

United States · US · US:59212-200_ffbc758d-7556-4269-8947-baa7ddb88541

Uroxatral

Orange BookUNIISPLATC G04CA01

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

Identification

ManufacturerAdvanz Pharma (US) Corp.
CountryUS (United States)
ATC codeG04CA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5921220010
    100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-10)
  • ndc11
    5921220030
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-30)

Annotations

UNII (FDA Substance ID)
75046A1XTN
ALFUZOSIN HYDROCHLORIDE
RxCUI 46043
Orange Book
N021287
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "75046A1XTN",
    "rxcui": "46043",
    "inchikey": "YTNKWDJILNVLGX-UHFFFAOYSA-N",
    "display_name": "ALFUZOSIN HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "9fc7f119-f36b-44cf-945d-940160f3afe3": {
      "match": "brand_token",
      "title": "UROXATRAL (ALFUZOSIN HCL) TABLET, EXTENDED RELEASE [ADVANZ PHARMA (US) CORP.]",
      "spl_version": "9",
      "published_date": "2025-01-03"
    }
  },
  "productid": "59212-200_ffbc758d-7556-4269-8947-baa7ddb88541",
  "productndc": "59212-200",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "021287",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jun 12, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALFUZOSIN HYDROCHLORIDE",
  "proprietary_name": "Uroxatral",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021287",
  "marketing_category": "NDA",
  "nonproprietary_name": "Alfuzosin HCl",
  "start_marketing_date": "20130603",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code G04CA01.

Access this data programmatically

Query Uroxatral and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.