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United States · US · US:0316-0165_4834365b-0f43-13a2-e063-6294a90a9f33

TRIDERM

In shortageOrange BookUNIISPLATC A01AC

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

Identification

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

Packs · 3

  • ndc11
    0316016515
    1 TUBE in 1 CARTON (0316-0165-15) / 15 g in 1 TUBE
  • ndc11
    0316016516
    1 JAR in 1 CARTON (0316-0165-16) / 454 g in 1 JAR
  • ndc11
    0316016585
    1 TUBE in 1 CARTON (0316-0165-85) / 85.2 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
F446C597KA
TRIAMCINOLONE ACETONIDE
RxCUI 10761
Orange Book
A088042
ATATAT
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": {
    "2c7fee2c-6f57-4de4-8803-98c0b31b07c3": {
      "match": "brand_token",
      "title": "TRIDERM (TRIAMCINOLONE ACETONIDE) CREAM [CROWN LABORATORIES]",
      "spl_version": "26",
      "published_date": "2026-01-14"
    }
  },
  "productid": "0316-0165_4834365b-0f43-13a2-e063-6294a90a9f33",
  "productndc": "0316-0165",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "088042",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.1%",
        "product_no": "001",
        "approval_date": "Mar 19, 1984"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.025%",
        "product_no": "002",
        "approval_date": "Mar 25, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.5%",
        "product_no": "003",
        "approval_date": "Mar 25, 2015"
      }
    ],
    "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": "TRIDERM",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA088042",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Triamcinolone Acetonide",
  "start_marketing_date": "19840319",
  "active_numerator_strength": ".25"
}

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