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United States · US · US:0054-3176_286734bc-8329-4f44-a20b-610cf7b67591

Dexamethasone Intensol

In shortageOrange BookUNIISPLATC A01AC02

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

Identification

ManufacturerHikma Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeA01AC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0054317644
    30 mL in 1 BOTTLE, GLASS (0054-3176-44)

Annotations

UNII (FDA Substance ID)
7S5I7G3JQL
DEXAMETHASONE
RxCUI 3264
Orange Book
A088252
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Dexamethasone Sodium Phosphate Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "7S5I7G3JQL",
    "rxcui": "3264",
    "inchikey": "UREBDLICKHMUKA-CXSFZGCWSA-N",
    "display_name": "DEXAMETHASONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "bf8acfdb-8dc8-4a69-90b0-33c680c421d6": {
      "match": "brand_token",
      "title": "DEXAMETHASONE TABLET [CARDINAL HEALTH 107, LLC]",
      "spl_version": "15",
      "published_date": "2026-05-25"
    }
  },
  "productid": "0054-3176_286734bc-8329-4f44-a20b-610cf7b67591",
  "productndc": "0054-3176",
  "dosage_form": "SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "088252",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1MG/ML",
        "product_no": "001",
        "approval_date": "Sep 1, 1983"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXAMETHASONE",
  "shortage_reason": "Dexamethasone Sodium Phosphate Injection",
  "shortage_status": "current",
  "proprietary_name": "Dexamethasone Intensol",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA088252",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dexamethasone Intensol",
  "start_marketing_date": "19830901",
  "active_numerator_strength": "1"
}

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