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United States · US · US:85437-093_42776e01-ac39-5aa4-e063-6294a90a99e9

Auranofin

Orange BookUNIISPLATC M01CB03

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

Identification

ManufacturerCoral Way Pharma, LLC
CountryUS (United States)
ATC codeM01CB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8543709306
    60 CAPSULE in 1 BOTTLE (85437-093-06)

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": {
    "d688978b-8b91-4377-9f1d-89b805f5747c": {
      "match": "brand_token",
      "title": "AURANOFIN CAPSULE [CORAL WAY PHARMA, LLC]",
      "spl_version": "2",
      "published_date": "2025-11-17"
    }
  },
  "productid": "85437-093_42776e01-ac39-5aa4-e063-6294a90a99e9",
  "productndc": "85437-093",
  "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": "Auranofin",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA018689",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "auranofin",
  "start_marketing_date": "20251029",
  "active_numerator_strength": "3"
}

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