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United States · US · US:45802-109_07fb530d-61a4-4d09-afe0-917f18985686

Triamcinolone Acetonide Nasal

In shortageOrange BookUNIISPLATC A01AC

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

Identification

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

Packs · 1

  • ndc11
    4580210901
    1 BOTTLE in 1 CARTON (45802-109-01) / 120 SPRAY, METERED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
F446C597KA
TRIAMCINOLONE ACETONIDE
RxCUI 10761
Orange Book
A078104
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": "NASAL",
  "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": "45802-109_07fb530d-61a4-4d09-afe0-917f18985686",
  "productndc": "45802-109",
  "dosage_form": "SPRAY, METERED",
  "orange_book": {
    "appl_no": "078104",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.055MG/SPRAY",
        "product_no": "001",
        "approval_date": "Jul 30, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.055MG/SPRAY",
        "product_no": "002",
        "approval_date": "Nov 14, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "TRIAMCINOLONE ACETONIDE",
  "shortage_reason": "Triamcinolone Hexacetonide Injection",
  "shortage_status": "current",
  "proprietary_name": "Triamcinolone Acetonide Nasal",
  "active_ingred_unit": "ug/1",
  "application_number": "ANDA078104",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Triamcinolone acetonide",
  "start_marketing_date": "20170328",
  "active_numerator_strength": "55"
}

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