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 · 6

ndc11
5528958204
4 TABLET in 1 BOTTLE, PLASTIC (55289-582-04)
ndc11
5528958206
6 TABLET in 1 BOTTLE, PLASTIC (55289-582-06)
ndc11
5528958210
10 TABLET in 1 BOTTLE, PLASTIC (55289-582-10)
ndc11
5528958215
15 TABLET in 1 BOTTLE, PLASTIC (55289-582-15)
ndc11
5528958221
21 TABLET in 1 BOTTLE, PLASTIC (55289-582-21)
ndc11
5528958228
28 TABLET in 1 BOTTLE, PLASTIC (55289-582-28)

Annotations

UNII (FDA Substance ID)

7S5I7G3JQL

DEXAMETHASONE

RxCUI 3264

Orange Book

A084612

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": "55289-582_2ac01b74-f082-65ff-e063-6394a90aa606",
  "productndc": "55289-582",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "084612",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.75MG",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "004",
        "approval_date": "Sep 15, 1983"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "1.5MG",
        "product_no": "005",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "006",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "6MG",
        "product_no": "007",
        "approval_date": "Sep 15, 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": "ANDA084612",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dexamethasone",
  "start_marketing_date": "19780719",
  "active_numerator_strength": "4"
}

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