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United States · US · US:24208-040_40a863fe-f804-71ae-e063-6294a90af8fa

Xipere

In shortageOrange BookUNIISPLATC A01AC

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

Identification

ManufacturerBausch & Lomb Incorporated
CountryUS (United States)
ATC codeA01AC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2420804001
    1 TRAY in 1 CARTON (24208-040-01) / 1 VIAL in 1 TRAY / .9 mL in 1 VIAL (24208-040-02)
  • ndc11
    2420804040
    1 TRAY in 1 CARTON (24208-040-40) / 1 VIAL in 1 TRAY / .9 mL in 1 VIAL (24208-040-41)

Annotations

UNII (FDA Substance ID)
F446C597KA
TRIAMCINOLONE ACETONIDE
RxCUI 10761
Orange Book
N211950
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": "OPHTHALMIC",
  "spl_meta": {
    "ea6ad429-967f-4f75-a33d-e06f849bee80": {
      "match": "brand_token",
      "title": "XIPERE (TRIAMCINOLONE ACETONIDE) INJECTION, SUSPENSION [BAUSCH & LOMB INCORPORATED]",
      "spl_version": "7",
      "published_date": "2025-11-17"
    }
  },
  "productid": "24208-040_40a863fe-f804-71ae-e063-6294a90af8fa",
  "productndc": "24208-040",
  "dosage_form": "INJECTION, SUSPENSION",
  "orange_book": {
    "appl_no": "211950",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "40MG/ML",
        "product_no": "001",
        "approval_date": "Oct 22, 2021"
      }
    ],
    "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": "Xipere",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA211950",
  "marketing_category": "NDA",
  "nonproprietary_name": "triamcinolone acetonide",
  "start_marketing_date": "20211217",
  "active_numerator_strength": "40"
}

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