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United States · US · US:0168-0005_4ecf8bca-6585-4eed-88c7-c261a622d1cd

Triamcinolone Acetonide

In shortageOrange BookUNIISPLATC A01AC

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

Identification

ManufacturerE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
CountryUS (United States)
ATC codeA01AC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0168000580
    80 g in 1 TUBE (0168-0005-80)

Annotations

UNII (FDA Substance ID)
F446C597KA
TRIAMCINOLONE ACETONIDE
RxCUI 10761
Orange Book
A085691
ATATAT
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Triamcinolone Acetonide Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "F446C597KA",
    "rxcui": "10761",
    "inchikey": "YNDXUCZADRHECN-JNQJZLCISA-N",
    "display_name": "TRIAMCINOLONE ACETONIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "b2ba93bc-3775-466b-8daf-4ffa3edc9c00": {
      "match": "brand_token",
      "title": "TRIAMCINOLONE ACETONIDE CREAM [BRYANT RANCH PREPACK]",
      "spl_version": "104",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0168-0005_4ecf8bca-6585-4eed-88c7-c261a622d1cd",
  "productndc": "0168-0005",
  "dosage_form": "OINTMENT",
  "orange_book": {
    "appl_no": "085691",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.025%",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.5%",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.1%",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRIAMCINOLONE ACETONIDE",
  "shortage_reason": "Triamcinolone Acetonide Injection",
  "shortage_status": "current",
  "proprietary_name": "Triamcinolone Acetonide",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA085691",
  "marketing_category": "ANDA",
  "nonproprietary_name": "triamcinolone acetonide",
  "start_marketing_date": "19780214",
  "active_numerator_strength": ".25"
}

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