DEXAMETHASONE

In shortageOrange BookUNIISPLATC A01AC02

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeA01AC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
7278953401
100 TABLET in 1 BOTTLE, PLASTIC (72789-534-01)
ndc11
7278953428
28 TABLET in 1 BOTTLE, PLASTIC (72789-534-28)
ndc11
7278953495
1000 TABLET in 1 BOTTLE, PLASTIC (72789-534-95)

Annotations

UNII (FDA Substance ID)

7S5I7G3JQL

DEXAMETHASONE

RxCUI 3264

Orange Book

A218372

ABABABABABABAB

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": "72789-534_4589a128-79eb-aa64-e063-6294a90a953b",
  "productndc": "72789-534",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "218372",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Sep 17, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.75MG",
        "product_no": "002",
        "approval_date": "Sep 17, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "003",
        "approval_date": "Sep 17, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1.5MG",
        "product_no": "004",
        "approval_date": "Sep 17, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "005",
        "approval_date": "Sep 17, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "006",
        "approval_date": "Sep 17, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "6MG",
        "product_no": "007",
        "approval_date": "Sep 17, 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": "ANDA218372",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DEXAMETHASONE",
  "start_marketing_date": "20251121",
  "active_numerator_strength": "4"
}

Related drugs

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