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United States · US · US:33342-384_4a96f732-bbce-426f-9780-89115cac638b

Silodosin

Orange BookUNIISPLATC G04CA04

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

Identification

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

Packs · 3

  • ndc11
    3334238407
    30 CAPSULE in 1 BOTTLE (33342-384-07)
  • ndc11
    3334238410
    90 CAPSULE in 1 BOTTLE (33342-384-10)
  • ndc11
    3334238412
    100 BLISTER PACK in 1 CARTON (33342-384-12) / 10 CAPSULE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
CUZ39LUY82
SILODOSIN
RxCUI 720825
Orange Book
A211166
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": "33342-384_4a96f732-bbce-426f-9780-89115cac638b",
  "productndc": "33342-384",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "211166",
    "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": "ANDA211166",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Silodosin",
  "start_marketing_date": "20181203",
  "active_numerator_strength": "4"
}

Related drugs

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