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United States · US · US:54766-093_431445cb-3625-82d8-e063-6394a90aeaea

RIDAURA

Orange BookUNIISPLATC M01CB03

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

Identification

ManufacturerSebela Pharmaceuticals Inc.
CountryUS (United States)
ATC codeM01CB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5476609306
    60 CAPSULE in 1 BOTTLE (54766-093-06)

Annotations

UNII (FDA Substance ID)
3H04W2810V
AURANOFIN
RxCUI 1227
Orange Book
N018689
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "3H04W2810V",
    "rxcui": "1227",
    "inchikey": "AUJRCFUBUPVWSZ-XTZHGVARSA-M",
    "display_name": "AURANOFIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "43ba3de1-ab2e-06f6-e054-00144ff8d46c": {
      "match": "brand_token",
      "title": "RIDAURA (AURANOFIN) CAPSULE [SEBELA PHARMACEUTICALS INC.]",
      "spl_version": "5",
      "published_date": "2025-11-17"
    }
  },
  "productid": "54766-093_431445cb-3625-82d8-e063-6394a90aeaea",
  "productndc": "54766-093",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "018689",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3MG",
        "product_no": "001",
        "approval_date": "May 24, 1985"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AURANOFIN",
  "proprietary_name": "RIDAURA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA018689",
  "marketing_category": "NDA",
  "nonproprietary_name": "auranofin",
  "start_marketing_date": "20161215",
  "active_numerator_strength": "3"
}

Related drugs

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