Dexmedetomidine Hydrochloride

In shortageOrange BookUNIISPLATC N05CM18

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeN05CM18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0143952610
10 POUCH in 1 CASE (0143-9526-10) / 1 BAG in 1 POUCH / 50 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

1018WH7F9I

DEXMEDETOMIDINE HYDROCHLORIDE

RxCUI 228054

Orange Book

A206407

APAPAP

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": "0143-9526_b39a45b9-3b3d-4719-8dfe-da16fd55ac10",
  "productndc": "0143-9526",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "206407",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)",
        "product_no": "001",
        "approval_date": "Jan 30, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)",
        "product_no": "002",
        "approval_date": "Jan 30, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)",
        "product_no": "003",
        "approval_date": "May 30, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXMEDETOMIDINE HYDROCHLORIDE",
  "shortage_reason": "Dexmedetomidine Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Dexmedetomidine Hydrochloride",
  "active_ingred_unit": "ug/mL",
  "application_number": "ANDA206407",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dexmedetomidine Hydrochloride",
  "start_marketing_date": "20200130",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code N05CM18.

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