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United States · US · US:47335-956_70258299-7c72-4a10-8d0c-4a5e3b2a0fc8

Alfuzosin Hydrochloride

Orange BookUNIISPLATC G04CA01

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeG04CA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    4733595608
    100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-956-08)
  • ndc11
    4733595618
    1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-956-18)
  • ndc11
    4733595681
    90 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-956-81)
  • ndc11
    4733595683
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-956-83)
  • ndc11
    4733595688
    100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-956-88)

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": "47335-956_70258299-7c72-4a10-8d0c-4a5e3b2a0fc8",
  "productndc": "47335-956",
  "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

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