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United States · US · US:71335-2405_2b25f3c5-1372-4e07-aaaf-55e6fca3c689

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 · 6

  • ndc11
    7133524051
    12 TABLET in 1 BOTTLE (71335-2405-1)
  • ndc11
    7133524052
    42 TABLET in 1 BOTTLE (71335-2405-2)
  • ndc11
    7133524053
    30 TABLET in 1 BOTTLE (71335-2405-3)
  • ndc11
    7133524054
    21 TABLET in 1 BOTTLE (71335-2405-4)
  • ndc11
    7133524055
    20 TABLET in 1 BOTTLE (71335-2405-5)
  • ndc11
    7133524056
    90 TABLET in 1 BOTTLE (71335-2405-6)

Annotations

UNII (FDA Substance ID)
7S5I7G3JQL
DEXAMETHASONE
RxCUI 3264
Orange Book
A215604
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": "71335-2405_2b25f3c5-1372-4e07-aaaf-55e6fca3c689",
  "productndc": "71335-2405",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "215604",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1.5MG",
        "product_no": "001",
        "approval_date": "Aug 8, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "002",
        "approval_date": "Aug 8, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "6MG",
        "product_no": "003",
        "approval_date": "Aug 8, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "004",
        "approval_date": "Oct 5, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.75MG",
        "product_no": "005",
        "approval_date": "Oct 5, 2023"
      }
    ],
    "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": "ANDA215604",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dexamethasone",
  "start_marketing_date": "20231009",
  "active_numerator_strength": ".75"
}

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