Alfuzosin Hydrochloride

Orange BookUNIISPLATC G04CA01

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeG04CA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
7133521461
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2146-1)
ndc11
7133521462
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2146-2)
ndc11
7133521463
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2146-3)
ndc11
7133521464
120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2146-4)
ndc11
7133521465
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2146-5)

Annotations

UNII (FDA Substance ID)

75046A1XTN

ALFUZOSIN HYDROCHLORIDE

RxCUI 46043

Orange Book

A079057

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": "71335-2146_20858b72-0778-46d6-be98-37d913c425b0",
  "productndc": "71335-2146",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "079057",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jul 18, 2011"
      }
    ],
    "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": "ANDA079057",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Alfuzosin Hydrochloride",
  "start_marketing_date": "20111122",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code G04CA01.

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