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United States · US · US:68047-702_4137ff08-7529-5862-e063-6294a90aade5

Dexamethasone

In shortageOrange BookUNIISPLATC A01AC02

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

Identification

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

Packs · 1

  • ndc11
    6804770201
    100 TABLET in 1 BOTTLE (68047-702-01)

Annotations

UNII (FDA Substance ID)
7S5I7G3JQL
DEXAMETHASONE
RxCUI 3264
Orange Book
A201270
AB
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": "68047-702_4137ff08-7529-5862-e063-6294a90aade5",
  "productndc": "68047-702",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "201270",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1.5MG",
        "product_no": "001",
        "approval_date": "Jul 17, 2017"
      }
    ],
    "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": "ANDA201270",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dexamethasone 1.5 mg",
  "start_marketing_date": "20170901",
  "active_numerator_strength": "1.5"
}

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