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United States · US · US:82111-955_d3488fd8-88b2-4f73-9fa4-fbcf14ddd972

Hemady

In shortageOrange BookUNIISPLATC A01AC02

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

Identification

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

Packs · 2

  • ndc11
    8211195501
    1 BOTTLE in 1 CARTON (82111-955-01) / 24 TABLET in 1 BOTTLE
  • ndc11
    8211195502
    1 BOTTLE in 1 CARTON (82111-955-02) / 100 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
7S5I7G3JQL
DEXAMETHASONE
RxCUI 3264
Orange Book
N211379
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": {
    "6b9cf32c-6d60-4853-bbfd-2304ffc2c129": {
      "match": "brand_token",
      "title": "HEMADY (DEXAMETHASONE) TABLET [EDENBRIDGE PHARMACEUTICALS LLC.]",
      "spl_version": "4",
      "published_date": "2026-01-26"
    }
  },
  "productid": "82111-955_d3488fd8-88b2-4f73-9fa4-fbcf14ddd972",
  "productndc": "82111-955",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211379",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Oct 3, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXAMETHASONE",
  "shortage_reason": "Dexamethasone Sodium Phosphate Injection",
  "shortage_status": "current",
  "proprietary_name": "Hemady",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA211379",
  "marketing_category": "NDA",
  "nonproprietary_name": "dexamethasone",
  "start_marketing_date": "20191003",
  "active_numerator_strength": "20"
}

Related drugs

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