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United States · US · US:46708-405_74147395-217c-4a7c-8acf-92a95ca7b7d4

Silodosin

Orange BookUNIISPLATC G04CA04

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

Identification

ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeG04CA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4670840530
    30 CAPSULE in 1 BOTTLE (46708-405-30)
  • ndc11
    4670840590
    90 CAPSULE in 1 BOTTLE (46708-405-90)
  • ndc11
    4670840591
    1000 CAPSULE in 1 BOTTLE (46708-405-91)

Annotations

UNII (FDA Substance ID)
CUZ39LUY82
SILODOSIN
RxCUI 720825
Orange Book
A211731
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "CUZ39LUY82",
    "rxcui": "720825",
    "inchikey": "PNCPYILNMDWPEY-QGZVFWFLSA-N",
    "display_name": "SILODOSIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "43f83422-680f-411e-bbc3-2b092e64a017": {
      "match": "brand_token",
      "title": "SILODOSIN CAPSULE [CREEKWOOD PHARMACEUTICALS LLC]",
      "spl_version": "4",
      "published_date": "2026-05-11"
    }
  },
  "productid": "46708-405_74147395-217c-4a7c-8acf-92a95ca7b7d4",
  "productndc": "46708-405",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "211731",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Nov 22, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "8MG",
        "product_no": "002",
        "approval_date": "Nov 22, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SILODOSIN",
  "proprietary_name": "Silodosin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211731",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Silodosin",
  "start_marketing_date": "20191125",
  "active_numerator_strength": "4"
}

Related drugs

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