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United States · US · US:76282-302_663c0846-dc2c-409f-9fe0-bf2901ff92da

Alfuzosin hydrochloride

Orange BookUNIISPLATC G04CA01

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

Identification

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

Packs · 5

  • ndc11
    7628230201
    100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-01)
  • ndc11
    7628230205
    500 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-05)
  • ndc11
    7628230210
    1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-10)
  • ndc11
    7628230212
    120 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-12)
  • ndc11
    7628230290
    90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76282-302-90)

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": "76282-302_663c0846-dc2c-409f-9fe0-bf2901ff92da",
  "productndc": "76282-302",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "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": "20121002",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code G04CA01.

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