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United States · US · US:69238-1420_36fb79b1-8d84-4afa-b26c-78a83394140d

Silodosin

Orange BookUNIISPLATC G04CA04

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

Identification

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

Packs · 2

  • ndc11
    6923814203
    30 CAPSULE in 1 BOTTLE (69238-1420-3)
  • ndc11
    6923814209
    90 CAPSULE in 1 BOTTLE (69238-1420-9)

Annotations

UNII (FDA Substance ID)
CUZ39LUY82
SILODOSIN
RxCUI 720825
Orange Book
A209745
ABAB
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": "69238-1420_36fb79b1-8d84-4afa-b26c-78a83394140d",
  "productndc": "69238-1420",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "209745",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Dec 3, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "002",
        "approval_date": "Dec 3, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SILODOSIN",
  "proprietary_name": "Silodosin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209745",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Silodosin",
  "start_marketing_date": "20181203",
  "active_numerator_strength": "8"
}

Related drugs

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