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United States · US · US:72789-351_40bb71ff-387e-bd53-e063-6394a90a38ef

SILODOSIN

Orange BookUNIISPLATC G04CA04

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG04CA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7278935130
    30 CAPSULE in 1 BOTTLE, PLASTIC (72789-351-30)

Annotations

UNII (FDA Substance ID)
CUZ39LUY82
SILODOSIN
RxCUI 720825
Orange Book
A210626
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": "72789-351_40bb71ff-387e-bd53-e063-6394a90a38ef",
  "productndc": "72789-351",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "210626",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Dec 10, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "002",
        "approval_date": "Dec 10, 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": "ANDA210626",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SILODOSIN",
  "start_marketing_date": "20181210",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code G04CA04.

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