DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

In shortageOrange BookUNIISPLATC N05CM18

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

Identification

ManufacturerSandoz Inc.

CountryUS (United States)

ATC codeN05CM18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0781349595
10 BOTTLE in 1 CARTON (0781-3495-95) / 100 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

1018WH7F9I

DEXMEDETOMIDINE HYDROCHLORIDE

RxCUI 228054

Orange Book

A209065

APAPAPAP

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": "0781-3495_fdf227d9-008e-60f8-e053-6294a90af5c4",
  "productndc": "0781-3495",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "209065",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)",
        "product_no": "001",
        "approval_date": "Sep 19, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)",
        "product_no": "002",
        "approval_date": "Jun 12, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)",
        "product_no": "003",
        "approval_date": "Jun 12, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)",
        "product_no": "004",
        "approval_date": "Jun 12, 2020"
      }
    ],
    "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 IN 0.9% SODIUM CHLORIDE",
  "active_ingred_unit": "ug/mL",
  "application_number": "ANDA209065",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE",
  "start_marketing_date": "20200612",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code N05CM18.

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