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United States · US · US:80425-0346_4250a0b0-e539-57c9-e063-6294a90a4b55

Dexamethasone

In shortageOrange BookUNIISPLATC A01AC02

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

Identification

ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC
CountryUS (United States)
ATC codeA01AC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    8042503461
    21 TABLET in 1 BOTTLE (80425-0346-1)
  • ndc11
    8042503462
    27 TABLET in 1 BOTTLE (80425-0346-2)
  • ndc11
    8042503463
    49 TABLET in 1 BOTTLE (80425-0346-3)
  • ndc11
    8042503464
    60 TABLET in 1 BOTTLE (80425-0346-4)

Annotations

UNII (FDA Substance ID)
7S5I7G3JQL
DEXAMETHASONE
RxCUI 3264
Orange Book
A201270
AB
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": "80425-0346_4250a0b0-e539-57c9-e063-6294a90a4b55",
  "productndc": "80425-0346",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "201270",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1.5MG",
        "product_no": "001",
        "approval_date": "Jul 17, 2017"
      }
    ],
    "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",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA201270",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dexamethasone",
  "start_marketing_date": "20230731",
  "active_numerator_strength": "1.5"
}

Related drugs

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