Dexmedetomidine Hydrochloride

In shortageOrange BookUNIISPLATC N05CM18

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

Identification

ManufacturerBaxter Healthcare Corporation

CountryUS (United States)

ATC codeN05CM18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
3600026205
5 VIAL, SINGLE-DOSE in 1 CARTON (36000-262-05) / 2 mL in 1 VIAL, SINGLE-DOSE (36000-262-01)
ndc11
3600026210
10 VIAL, SINGLE-DOSE in 1 CARTON (36000-262-10) / 2 mL in 1 VIAL, SINGLE-DOSE (36000-262-01)
ndc11
3600026225
25 VIAL, SINGLE-DOSE in 1 CARTON (36000-262-25) / 2 mL in 1 VIAL, SINGLE-DOSE (36000-262-01)

Annotations

UNII (FDA Substance ID)

1018WH7F9I

DEXMEDETOMIDINE HYDROCHLORIDE

RxCUI 228054

Orange Book

A208103

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": "36000-262_f0a53e8e-e8cc-4b2d-b8f0-2d99b01f6cc2",
  "productndc": "36000-262",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "208103",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)",
        "product_no": "001",
        "approval_date": "Apr 15, 2026"
      }
    ],
    "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": "ANDA208103",
  "marketing_category": "ANDA",
  "nonproprietary_name": "dexmedetomidine hydrochloride",
  "start_marketing_date": "20260416",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code N05CM18.

Access this data programmatically

Query Dexmedetomidine Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs