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United States · US · US:70954-872_5d9b22ca-c619-4ee3-98eb-74544d0d5cb3

Dexamethasone

In shortageOrange BookUNIISPLATC A01AC02

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

Identification

ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA01AC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7095487210
    1 BOTTLE in 1 CARTON (70954-872-10) / 237 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
7S5I7G3JQL
DEXAMETHASONE
RxCUI 3264
Orange Book
A084754
AA
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": "70954-872_5d9b22ca-c619-4ee3-98eb-74544d0d5cb3",
  "productndc": "70954-872",
  "dosage_form": "ELIXIR",
  "orange_book": {
    "appl_no": "084754",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "0.5MG/5ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "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/5mL",
  "application_number": "ANDA084754",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dexamethasone",
  "start_marketing_date": "20251201",
  "active_numerator_strength": ".5"
}

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