Dexamethasone

In shortageOrange BookUNIISPLATC A01AC02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAlvogen Inc.

CountryUS (United States)

ATC codeA01AC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4778191601
100 TABLET in 1 BOTTLE (47781-916-01)

Annotations

UNII (FDA Substance ID)

7S5I7G3JQL

DEXAMETHASONE

RxCUI 3264

Orange Book

A088481

ABBPBPAB

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": "47781-916_f5d1d20f-dcb0-9ddf-b436-165cf014f5fa",
  "productndc": "47781-916",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "088481",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "6MG",
        "product_no": "001",
        "approval_date": "Nov 28, 1983"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "BP",
        "strength": "0.5MG",
        "product_no": "002",
        "approval_date": "Apr 28, 1983"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "BP",
        "strength": "0.75MG",
        "product_no": "003",
        "approval_date": "Apr 28, 1983"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "004",
        "approval_date": "Apr 28, 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",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA088481",
  "marketing_category": "ANDA",
  "nonproprietary_name": "dexamethasone",
  "start_marketing_date": "20210628",
  "active_numerator_strength": "6"
}

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