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United States · US · US:82682-001_7aad2f23-85cb-4228-8460-aef6676cc11f

KOURZEQ

In shortageOrange BookUNIISPLATC A01AC

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

Identification

ManufacturerMidAmerica Pharmaceuticals
CountryUS (United States)
ATC codeA01AC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8268200105
    1 TUBE in 1 CARTON (82682-001-05) / 5 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
F446C597KA
TRIAMCINOLONE ACETONIDE
RxCUI 10761
Orange Book
A040771
AT
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Triamcinolone Hexacetonide 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": {
    "aad48d1e-f8db-4020-92af-0b3258bbc0f2": {
      "match": "brand_token",
      "title": "KOURZEQ (TRIAMCINOLONE ACETONIDE) PASTE [MIDAMERICA PHARMACEUTICALS]",
      "spl_version": "7",
      "published_date": "2025-11-19"
    }
  },
  "productid": "82682-001_7aad2f23-85cb-4228-8460-aef6676cc11f",
  "productndc": "82682-001",
  "dosage_form": "PASTE",
  "orange_book": {
    "appl_no": "040771",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.1%",
        "product_no": "001",
        "approval_date": "Jul 1, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRIAMCINOLONE ACETONIDE",
  "shortage_reason": "Triamcinolone Hexacetonide Injection",
  "shortage_status": "current",
  "proprietary_name": "KOURZEQ",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA040771",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Triamcinolone Acetonide",
  "start_marketing_date": "20230915",
  "active_numerator_strength": "1"
}

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