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United States · US · US:71335-3054_015805cd-1e17-4e86-9a37-668597065f48

Dexamethasone

In shortageOrange BookUNIISPLATC A01AC02

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeA01AC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 10

  • ndc11
    7133530540
    4 TABLET in 1 BOTTLE (71335-3054-0)
  • ndc11
    7133530541
    30 TABLET in 1 BOTTLE (71335-3054-1)
  • ndc11
    7133530542
    6 TABLET in 1 BOTTLE (71335-3054-2)
  • ndc11
    7133530543
    3 TABLET in 1 BOTTLE (71335-3054-3)
  • ndc11
    7133530544
    15 TABLET in 1 BOTTLE (71335-3054-4)
  • ndc11
    7133530545
    40 TABLET in 1 BOTTLE (71335-3054-5)
  • ndc11
    7133530546
    60 TABLET in 1 BOTTLE (71335-3054-6)
  • ndc11
    7133530547
    28 TABLET in 1 BOTTLE (71335-3054-7)
  • ndc11
    7133530548
    90 TABLET in 1 BOTTLE (71335-3054-8)
  • ndc11
    7133530549
    10 TABLET in 1 BOTTLE (71335-3054-9)

Annotations

UNII (FDA Substance ID)
7S5I7G3JQL
DEXAMETHASONE
RxCUI 3264
Orange Book
A216282
ABABABABAB
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": "71335-3054_015805cd-1e17-4e86-9a37-668597065f48",
  "productndc": "71335-3054",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216282",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Feb 7, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.75MG",
        "product_no": "002",
        "approval_date": "Feb 7, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1.5MG",
        "product_no": "003",
        "approval_date": "Feb 7, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "004",
        "approval_date": "Feb 7, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "6MG",
        "product_no": "005",
        "approval_date": "Feb 7, 2024"
      }
    ],
    "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": "ANDA216282",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dexamethasone",
  "start_marketing_date": "20240415",
  "active_numerator_strength": "4"
}

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