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United States · US · US:63187-661_6ea8b135-ac8a-4a01-9b3e-0440562af45c

KENALOG-40

In shortageOrange BookUNIISPLATC A01AC

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeA01AC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6318766101
    1 VIAL, SINGLE-DOSE in 1 CARTON (63187-661-01) / 1 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
F446C597KA
TRIAMCINOLONE ACETONIDE
RxCUI 10761
Orange Book
N014901
AB
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": "INTRA-ARTICULAR; INTRAMUSCULAR",
  "spl_meta": {
    "4ce116aa-b330-4da9-9cdd-ba8e6be0c4ad": {
      "match": "brand_token",
      "title": "KENALOG-40 (TRIAMCINOLONE ACETONIDE) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS]",
      "spl_version": "23",
      "published_date": "2026-01-06"
    }
  },
  "productid": "63187-661_6ea8b135-ac8a-4a01-9b3e-0440562af45c",
  "productndc": "63187-661",
  "dosage_form": "INJECTION, SUSPENSION",
  "orange_book": {
    "appl_no": "014901",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "40MG/ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "80MG/ML",
        "product_no": "002",
        "approval_date": "Apr 12, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRIAMCINOLONE ACETONIDE",
  "shortage_reason": "Triamcinolone Hexacetonide Injection",
  "shortage_status": "current",
  "proprietary_name": "KENALOG-40",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA014901",
  "marketing_category": "NDA",
  "nonproprietary_name": "TRIAMCINOLONE ACETONIDE",
  "start_marketing_date": "20090601",
  "active_numerator_strength": "40"
}

Related drugs

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