Precedex

In shortageOrange BookUNIISPLATC N05CM18

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

Identification

ManufacturerHospira, Inc.

CountryUS (United States)

ATC codeN05CM18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0409787512
12 POUCH in 1 CASE (0409-7875-12) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-7875-01)

Annotations

UNII (FDA Substance ID)

1018WH7F9I

DEXMEDETOMIDINE HYDROCHLORIDE

RxCUI 228054

Orange Book

N021038

APAPAPAPAP

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": {
    "9eb336de-5fa5-4b46-b40b-a7ca5a0864bd": {
      "match": "brand_token",
      "title": "PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HENRY SCHEIN, INC.]",
      "spl_version": "9",
      "published_date": "2026-05-28"
    }
  },
  "productid": "0409-7875_3c5274fd-6597-4b88-babc-92e4e16c6329",
  "productndc": "0409-7875",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "021038",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)",
        "product_no": "001",
        "approval_date": "Dec 17, 1999"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)",
        "product_no": "002",
        "approval_date": "Mar 13, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)",
        "product_no": "003",
        "approval_date": "Mar 13, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)",
        "product_no": "004",
        "approval_date": "Nov 14, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)",
        "product_no": "005",
        "approval_date": "Jan 31, 2020"
      }
    ],
    "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": "Precedex",
  "active_ingred_unit": "ug/mL",
  "application_number": "NDA021038",
  "marketing_category": "NDA",
  "nonproprietary_name": "DEXMEDETOMIDINE HYDROCHLORIDE",
  "start_marketing_date": "20250324",
  "active_numerator_strength": "4"
}

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