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Dexmedetomidine in Dextrose

Dexmedetomidine · Injection

Prescription NDA TE AP RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Dexmedetomidine in Dextrose
Generic name
Dexmedetomidine
Dosage form
Injection
Route
Intravenous
Marketing category
NDA · NDA
Labeler
WG Critical Care, LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
2
Data completeness
55% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Dexmedetomidine Hydrochloride 4 ug/mL 1718906 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection
Route of administration
Intravenous
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Adrenergic alpha2-Agonists [MoA] MoA All 44 members
Central alpha-2 Adrenergic Agonist [EPC] EPC All 44 members
General Anesthesia [PE] PE All 29 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
206628
Application type
NDA · New Drug Application
Approval date
October 21, 2015
Sponsor
HQ SPCLT PHARMA
Products on application
4
Submissions recorded
6
Products approved under application 206628.
Product Trade name Form Strength Ingredient Status TE Flags
206628-001 DEXMEDETOMIDINE HYDROCHLORIDE SOLUTION DEXMEDETOMIDINE HYDROCHLORIDE Prescription AP RLD
206628-002 DEXMEDETOMIDINE HYDROCHLORIDE SOLUTION DEXMEDETOMIDINE HYDROCHLORIDE Prescription AP RLD RS
206628-003 DEXMEDETOMIDINE HYDROCHLORIDE SOLUTION DEXMEDETOMIDINE HYDROCHLORIDE Prescription — RLD
206628-004 DEXMEDETOMIDINE HYDROCHLORIDE SOLUTION DEXMEDETOMIDINE HYDROCHLORIDE Prescription — RLD

Therapeutic equivalence

Source: Orange Book
TE code
AP
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated (parenteral aqueous solutions)

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
9717796 April 20, 2036 003 No June 26, 2018
9649296 April 20, 2036 003 No June 26, 2018
9717796 April 20, 2036 004 No June 26, 2018
9649296 April 20, 2036 004 No June 26, 2018

Approval history

Source: Drugs@FDA
Most recent submissions on application 206628.
Type No. Action Status Date Review
Supplement 24 Labeling Approved May 1, 2026 Standard
Supplement 5 Labeling Approved March 21, 2024 Standard
Supplement 17 Manufacturing (CMC) Approved June 7, 2021 N/A
Supplement 2 Efficacy Approved September 19, 2016 Standard
Supplement 1 Manufacturing (CMC) Approved February 9, 2016 Standard
Original application 1 Type 5 - New Formulation or New Manufacturer Approved October 21, 2015 Standard

Review documents

  • 0 · Supplement · May 5, 2026
  • 0 · Supplement · May 4, 2026
  • 0 · Supplement · March 25, 2024
  • 0 · Supplement · March 22, 2024
  • 0 · Supplement · August 25, 2023
  • 0 · Supplement · August 23, 2023
  • 0 · Supplement · September 21, 2016
  • 0 · Supplement · September 21, 2016
  • 0 · Original application · May 27, 2016
  • 0 · Original application · October 26, 2015
  • 0 · Original application · October 23, 2015

Adverse event reports

Source: openFDA FAERS
2,951
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: DEXMEDETOMIDINE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Shortages

Source: FDA Drug Shortages
Availability records from the FDA Drug Shortages database.
Status Availability Company Presentation Updated
Current Available HQ Specialty Pharma Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 44567-602-24) August 17, 2026
Current Available HQ Specialty Pharma Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 44567-603-24) August 17, 2026

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
44567-602-24 44567-602 WG Critical Care, LLC 24 BAG in 1 CARTON (44567-602-24) / 50 mL in 1 BAG October 18, 2018
44567-603-24 44567-603 WG Critical Care, LLC 24 BAG in 1 CARTON (44567-603-24) / 100 mL in 1 BAG October 18, 2018
44567-602 44567-602 WG Critical Care, LLC — April 19, 2016
44567-603 44567-603 WG Critical Care, LLC — April 19, 2016

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts
Drug Shortages FDA Supply availability

Generated September 25, 2026 · 12 sections on this page.