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United States · US · US:25021-052_688efb4d-213e-453d-add7-9875a6a19485

Dexamethasone Sodium Phosphate

In shortageOrange BookUNIISPLATC A01AC02

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

Identification

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

Packs · 2

  • ndc11
    2502105201
    25 VIAL in 1 CARTON (25021-052-01) / 1 mL in 1 VIAL
  • ndc11
    2502105205
    25 VIAL in 1 CARTON (25021-052-05) / 5 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
AI9376Y64P
DEXAMETHASONE SODIUM PHOSPHATE
RxCUI 48933
Orange Book
A215654
APAP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Dexamethasone Sodium Phosphate Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "AI9376Y64P",
    "rxcui": "48933",
    "inchikey": "PLCQGRYPOISRTQ-FCJDYXGNSA-L",
    "display_name": "DEXAMETHASONE SODIUM PHOSPHATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE",
  "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": "25021-052_688efb4d-213e-453d-add7-9875a6a19485",
  "productndc": "25021-052",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "215654",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 4MG PHOSPHATE/ML",
        "product_no": "001",
        "approval_date": "Aug 4, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 10MG PHOSPHATE/ML",
        "product_no": "002",
        "approval_date": "Sep 25, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXAMETHASONE SODIUM PHOSPHATE",
  "shortage_reason": "Dexamethasone Sodium Phosphate Injection",
  "shortage_status": "current",
  "proprietary_name": "Dexamethasone Sodium Phosphate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA215654",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dexamethasone Sodium Phosphate",
  "start_marketing_date": "20241201",
  "active_numerator_strength": "4"
}

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