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United States · US · US:45802-049_13c13dae-7f5d-4b1f-af06-c62dfdcf8f1c

Triamcinolone Acetonide

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
    4580204935
    1 TUBE in 1 CARTON (45802-049-35) / 15 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
F446C597KA
TRIAMCINOLONE ACETONIDE
RxCUI 10761
Orange Book
A087385
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": "45802-049_13c13dae-7f5d-4b1f-af06-c62dfdcf8f1c",
  "productndc": "45802-049",
  "dosage_form": "OINTMENT",
  "orange_book": {
    "appl_no": "087385",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "0.5%",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "0.025%",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "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": "ANDA087385",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Triamcinolone Acetonide",
  "start_marketing_date": "20061110",
  "active_numerator_strength": "5"
}

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