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Active Shortage Injection Anesthesia

Dexmedetomidine Hydrochloride Injection

Brand: DEXMEDETOMIDINE HYDROCHLORIDE

This drug is currently listed as in shortage by the FDA. Affected manufacturer: Gland Pharma Limited.

Active FDA Drug Shortage

Contact your pharmacist if you are affected. They can check availability from other manufacturers or suggest alternatives.

Shortage Details

Generic Name
Dexmedetomidine Hydrochloride Injection
Manufacturer
Gland Pharma Limited
Dosage Form
Injection
Presentation
Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-976-58)
Package NDC
43598-976-58

Status & Timeline

Status
Active Shortage
Availability
Available
First Reported
Apr 10, 2020
Last Updated
Sep 29, 2025
Therapeutic Category
Anesthesia

Shortage Reason

Distributed by DRL

Nearby — Other Dexmedetomidine Shortage Records

Frequently Asked Questions

Why is Dexmedetomidine in shortage?
According to FDA data: Distributed by DRL
What can I do if my medication is in shortage?
Contact your pharmacist — they can check availability across suppliers or suggest an equivalent from a different manufacturer. Your prescriber may also recommend a therapeutic substitute from the same drug class.
How often is this data updated?
Shortage data comes from the FDA Drug Shortages Database via openFDA. The database is updated regularly as manufacturers report changes to the FDA.

What This Dexmedetomidine Shortage Record Means

The FDA Drug Shortages database lists this record for Dexmedetomidine Hydrochloride Injection (brand: DEXMEDETOMIDINE HYDROCHLORIDE) from Gland Pharma Limited with a current status of Active Shortage. The affected dosage form is Injection, presented as Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-976-58). Shortages are tracked at the manufacturer and presentation level — other manufacturers or formulations of the same generic may remain available, which is why pharmacists often can source a working substitute even when one record is flagged.

This shortage was first reported on Apr 10, 2020 and was last updated Sep 29, 2025. The FDA cites the following reason: Distributed by DRL. There are 6 other current records in this database covering the same generic, which gives a fuller picture of how disruption is playing out across manufacturers and dosage forms.

A shortage listing is a supply-side signal, not a patient-level instruction. Access can vary dramatically by pharmacy, region, hospital system, and insurance formulary — local pharmacists have real-time visibility that a national database cannot provide. Therapeutic substitutes often exist in the same class, but switching decisions belong with your prescriber, who weighs efficacy, dosing conversion, interaction profile, and personal history. This page summarizes public FDA data for educational reference only and is not medical advice. If your medication is affected, contact your pharmacist and prescriber to plan an appropriate response.

Disclaimer: This information comes from the FDA Drug Shortages Database and is for educational purposes only. It is not medical advice. Do not stop or change any medication without consulting your healthcare provider or pharmacist. Shortage status can change rapidly — always verify current availability with your pharmacist.