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United States · US · US:69097-844_497e0a60-9b09-4dcc-8cc6-1f13196f2db4

Alfuzosin Hydrochloride

Orange BookUNIISPLATC G04CA01

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

Identification

ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeG04CA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6909784402
    30 TABLET in 1 BOTTLE (69097-844-02)
  • ndc11
    6909784405
    90 TABLET in 1 BOTTLE (69097-844-05)
  • ndc11
    6909784407
    100 TABLET in 1 BOTTLE (69097-844-07)
  • ndc11
    6909784412
    500 TABLET in 1 BOTTLE (69097-844-12)

Annotations

UNII (FDA Substance ID)
75046A1XTN
ALFUZOSIN HYDROCHLORIDE
RxCUI 46043
Orange Book
A090284
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": "69097-844_497e0a60-9b09-4dcc-8cc6-1f13196f2db4",
  "productndc": "69097-844",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090284",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jan 17, 2012"
      }
    ],
    "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": "ANDA090284",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Alfuzosin Hydrochloride",
  "start_marketing_date": "20160630",
  "active_numerator_strength": "10"
}

Related drugs

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