Dexmedetomidine in Dextrose

In shortageOrange BookUNIISPLATC N05CM18

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerWG Critical Care, LLC

CountryUS (United States)

ATC codeN05CM18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4456760324
24 BAG in 1 CARTON (44567-603-24) / 100 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

1018WH7F9I

DEXMEDETOMIDINE HYDROCHLORIDE

RxCUI 228054

Orange Book

N206628

APAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Dexmedetomidine Hydrochloride Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "1018WH7F9I",
    "rxcui": "228054",
    "inchikey": "VPNGEIHDPSLNMU-MERQFXBCSA-N",
    "display_name": "DEXMEDETOMIDINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "f140de5a-f13d-46b4-a742-049c63e474f5": {
      "match": "brand_token",
      "title": "DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]",
      "spl_version": "4",
      "published_date": "2026-05-29"
    }
  },
  "productid": "44567-603_42a0bb50-be84-4c46-abfd-fd44c6f10087",
  "productndc": "44567-603",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "206628",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)",
        "product_no": "001",
        "approval_date": "Oct 21, 2015"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)",
        "product_no": "002",
        "approval_date": "Oct 21, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)",
        "product_no": "003",
        "approval_date": "Jun 22, 2018"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)",
        "product_no": "004",
        "approval_date": "Jun 22, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXMEDETOMIDINE HYDROCHLORIDE",
  "shortage_reason": "Dexmedetomidine Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Dexmedetomidine in Dextrose",
  "active_ingred_unit": "ug/mL",
  "application_number": "NDA206628",
  "marketing_category": "NDA",
  "nonproprietary_name": "Dexmedetomidine",
  "start_marketing_date": "20160419",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code N05CM18.

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