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United States · US · US:51655-967_4974b10e-b8f0-5aa8-e063-6294a90acd65

Alfuzosin hydrochloride

Orange BookUNIISPLATC G04CA01

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

Identification

ManufacturerNorthwind Health Company, LLC
CountryUS (United States)
ATC codeG04CA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5165596752
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-967-52)

Annotations

UNII (FDA Substance ID)
75046A1XTN
ALFUZOSIN HYDROCHLORIDE
RxCUI 46043
Orange Book
A203192
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": {
    "37e89394-af6e-4700-bfa8-2effba1a286b": {
      "match": "brand_token",
      "title": "ALFUZOSIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]",
      "spl_version": "2",
      "published_date": "2026-05-11"
    }
  },
  "productid": "51655-967_4974b10e-b8f0-5aa8-e063-6294a90acd65",
  "productndc": "51655-967",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "203192",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jan 28, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALFUZOSIN HYDROCHLORIDE",
  "proprietary_name": "Alfuzosin hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203192",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Alfuzosin hydrochloride",
  "start_marketing_date": "20230629",
  "active_numerator_strength": "10"
}

Related drugs

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