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United States · US · US:0078-0897_4e6e468e-47e6-3f48-e063-6294a90a035d

TRIESENCE

In shortageOrange BookUNIISPLATC A01AC

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

Identification

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

Packs · 1

  • ndc11
    0078089778
    1 BLISTER PACK in 1 CARTON (0078-0897-78) / 1 VIAL, GLASS in 1 BLISTER PACK / 1 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
F446C597KA
TRIAMCINOLONE ACETONIDE
RxCUI 10761
Orange Book
N022048
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": "OPHTHALMIC",
  "spl_meta": {
    "22692d92-1359-9252-e063-6394a90ab669": {
      "match": "brand_token",
      "title": "TRIESENCE (TRIAMCINOLONE ACETONIDE) INJECTION, SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "2",
      "published_date": "2026-04-02"
    }
  },
  "productid": "0078-0897_4e6e468e-47e6-3f48-e063-6294a90a035d",
  "productndc": "0078-0897",
  "dosage_form": "INJECTION, SUSPENSION",
  "orange_book": {
    "appl_no": "022048",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "40MG/ML (40MG/ML)",
        "product_no": "001",
        "approval_date": "Nov 29, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRIAMCINOLONE ACETONIDE",
  "shortage_reason": "Triamcinolone Acetonide Injection",
  "shortage_status": "current",
  "proprietary_name": "TRIESENCE",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA022048",
  "marketing_category": "NDA",
  "nonproprietary_name": "triamcinolone acetonide",
  "start_marketing_date": "20241001",
  "active_numerator_strength": "40"
}

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