Dexmedetomidine Hydrochloride Injection (Precedex) shortage

Dexmedetomidine Hydrochloride Injection (brand names Precedex and Dexmedetomidine IN Dextrose) is recorded by the U.S. Food and Drug Administration (FDA) with a shortage status of Current, covering 14 affected presentations across 5 strengths, first posted 2020-04-10 and last updated 2026-08-20. 6 companies report it — Accord Healthcare Inc., Azurity Pharmaceuticals, Inc, Baxter Healthcare, HQ Specialty Pharma, Mylan Institutional, A Viatris Company and Par Health, Usa LLC — across 14 source lines. The strengths listed are 100 ug/1 mL, 200 ug/50 mL, 4 ug/1 mL, 400 mcg/100 mL (4 ug/1 mL) and 400 ug/100 mL. 23 package NDCs are referenced, under 8 FDA application numbers and 1 substance identifier. The FDA files it under Anesthesia. Of the 2 brand names shown, 1 was verified against RxNorm and 1 came from the FDA record. Every line is reproduced below with its company, presentation, package NDC and the FDA's own availability text, so each can be checked individually. Confirm the live status at the official FDA shortage record before relying on it: this page is regulatory supply information only, it is not medical advice, it does not assess clinical impact, and it never suggests a substitute.

Regulatory snapshot

FDA shortage status Current
Since (first posted) 2020-04-10
Last updated 2026-08-20
Affected presentations 14
Strengths listed 5 (100 ug/1 mL, 200 ug/50 mL, 4 ug/1 mL, 400 mcg/100 mL (4 ug/1 mL), 400 ug/100 mL)
Reporting manufacturers 6
Brand names 2 (Precedex, Dexmedetomidine IN Dextrose)
Generic name Dexmedetomidine Hydrochloride Injection
Product form Injection
Therapeutic category Anesthesia
Package NDCs listed 23
openFDA source rows 14
Official source https://www.accessdata.fda.gov/scripts/drugshortages/

Also known as

Dexmedetomidine Hydrochloride Injection is marketed under the brand names Precedex, Dexmedetomidine IN Dextrose. Brand names are never inferred on this site: each one below carries the source that vouches for it, so a name published by the FDA and a name resolved from the U.S. National Library of Medicine's RxNorm vocabulary can always be told apart. RxNorm mappings are resolved at ingestion time from the RxNorm concept identifiers openFDA publishes on the shortage record itself, and are accepted only when the brand concept's ingredient set matches the source product's exactly.

Brand nameSourceConcept identifierResolved
Dexmedetomidine IN Dextrose FDA / openFDA record
Precedex RxNorm (NLM) RxCUI 262138 (BN) 2026-08-21

1 of 2 name(s) resolved through RxNorm; 1 taken from the FDA record itself.

Affected presentations, companies and availability

The FDA publishes one line per reported package presentation and reporting company. All 14 line(s) behind this entry are reproduced below — company, presentation, strength, package NDC, status, the agency's availability text verbatim, and the date each line was last updated — so any single line can be checked against the official record without leaving this page. No line becomes a page of its own.

Reporting companyPresentationStrengthPackage NDCStatusAvailability (FDA text)Updated
Par Health, Usa LLC Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 42023-146-25) 100 ug/1 mL 42023-146-25 Current Available 2026-08-18
Baxter Healthcare Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 0338-9557-12) 400 ug/100 mL 0338-9557-12 Current Available 2026-08-17
Par Health, Usa LLC Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-186-20) 4 ug/1 mL 42023-186-20 Current Unavailable 2026-08-18
HQ Specialty Pharma Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 44567-602-24) 4 ug/1 mL 44567-602-24 Current Available 2026-08-17
Mylan Institutional, A Viatris Company Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 67457-925-10) 400 ug/100 mL 67457-925-10 Current Available 2026-08-20
Baxter Healthcare Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 43066-557-12) 400 ug/100 mL 43066-557-12 Current Available 2026-08-17
Mylan Institutional, A Viatris Company Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 67457-251-02) 100 ug/1 mL 67457-251-02 Current Available 2026-08-20
Accord Healthcare Inc. Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-239-93) 100 ug/1 mL 16729-239-93 Current Unavailable 2026-08-17
HQ Specialty Pharma Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 44567-601-04) 100 ug/1 mL 44567-601-04 Current Available 2026-08-17
Par Health, Usa LLC Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-187-10) 4 ug/1 mL 42023-187-10 Current Unavailable 2026-08-18
Mylan Institutional, A Viatris Company Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 67457-924-50) 200 ug/50 mL 67457-924-50 Current Available 2026-08-20
Azurity Pharmaceuticals, Inc Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 72572-128-08) 400 mcg/100 mL (4 ug/1 mL) 72572-128-08 Current Available 2026-08-17
Baxter Healthcare Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 43066-555-24) 200 ug/50 mL 43066-555-24 Current Available 2026-08-17
Baxter Healthcare Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 0338-9555-24) 200 ug/50 mL 0338-9555-24 Current Unavailable 2026-08-17

FDA application number(s) recorded against the affected products: ANDA202881, ANDA203972, ANDA204023, ANDA208266, ANDA208532, ANDA212571, ANDA212791, NDA206628. Substance identifier(s) (UNII): 1018WH7F9I.

Reporting manufacturers (6)

Each company below filed at least one of the source lines above. The record counts shown are coverage-limited activity signals from the indexed datasets — never quality ratings.

CompanyLines filed hereIndexed recordsRecallsShortage entries
Accord Healthcare Inc. 1 7 1 6
Azurity Pharmaceuticals, Inc 1 1 0 1
Baxter Healthcare 4 14 0 14
HQ Specialty Pharma 2 1 0 1
Mylan Institutional, A Viatris Company 3 6 0 6
Par Health, Usa LLC 3 3 1 2

Reason recorded by the FDA

Reproduced verbatim from the FDA's shortage record as a regulatory data field — not restated, summarised or interpreted here.

Related shortages

Every link below comes from a relation in the FDA data itself — a shared substance identifier, a shared reporting company, or a shared FDA therapeutic category — ordered by the strength of that overlap. Nothing here is a popularity list or an editorial suggestion.

Reported by the same companies

Same FDA therapeutic category

How to interpret this shortage record

A drug-shortage entry means the FDA has logged a reported supply constraint for a product as part of its public shortage tracking. The status (Current) describes where the shortage sits in its lifecycle according to the agency's data. Because the FDA publishes one line per reported package and reporting company, this page consolidates 14 such lines into the single shortage they describe; each line remains listed below with its own company, presentation and availability text so it can be checked individually against the source. A shortage entry is an administrative supply signal — it does not describe the clinical role of the product, does not suggest any substitute, and does not indicate that any specific patient is affected. Read this entry as a pointer to the official FDA shortage listing and confirm the live status there before relying on it.

What an FDA shortage entry is

A drug-shortage entry of this kind is an administrative supply-status record that the FDA maintains and publishes for transparency and reference. It names the affected product, attributes the report to the companies shown above, and records a status marking where the shortage sits within the agency's public tracking lifecycle at the time it was ingested by this site. The FDA publishes one line per reported package presentation and reporting company, so this entry is assembled from 14 such lines rather than one page per line. The earliest initial posting date across them is 2020-04-10, and the latest update 2026-08-20. The FDA files this product under Anesthesia in its own therapeutic categorisation, which is reproduced here as a source field and carries no clinical meaning on this page. All values shown here are reproduced as regulatory data points from the official FDA drug-shortages dataset to help you find and verify the original entry. This page does not advise on therapeutic substitution, does not assess clinical impact, and is not a recommendation of any kind.

Why this page has one address

This page's address is derived from the shortage's own identity — the product name as the FDA publishes it, including the form in which it is supplied — and not from the entry's status, from the reporting company, or from the order in which the openFDA API happened to return its rows. That means the address stays the same when the status changes from current to resolved, when another company is added to the same shortage, or when a further package presentation is reported. Distinct product forms of the same molecule — an injection and an oral capsule, say — remain distinct pages, because the FDA tracks them as separate shortages. 29 earlier addresses for this entry redirect here permanently, so previously published links continue to resolve.

What this record does not mean

This shortage record does not constitute medical advice and does not tell you whether to start, stop, switch, or avoid any product. It does not assess safety for any individual, does not provide dosage, treatment, or therapeutic guidance, and does not diagnose any condition. The dataset is coverage-limited: it reflects what the FDA has published in the indexed source at ingestion time, which may lag the live record and may omit details held only in primary documents. For any health decision, consult a qualified healthcare professional, and for the authoritative record consult the FDA directly through the linked official source.

Source-row notes

Source-derived regulatory summary

The text in this section is generated from the FDA source fields shown elsewhere on this page. It is regulatory information only — not medical advice — and adds no facts beyond the official record.

This record pertains to Dexmedetomidine Hydrochloride Injection, a product available in a presentation of 400 ug/100 mL. It is associated with the company Mylan Institutional, A Viatris Company, and is classified under anesthesia. The product has been listed since April 10, 2020, and the last update was on August 20, 2026.

Regulatory context

The status of 'Current' indicates that this product is actively available in the market. The classification as 'Available' means that it can be obtained by healthcare providers or institutions. The NDC (National Drug Code) provided helps in identifying the specific formulation and packaging of the product.

  • Drug shortage
  • Status: Current
  • Dexmedetomidine Hydrochloride Injection
  • Mylan Institutional, A Viatris Company

Fields used include generic_name, status, presentation, availability, company_name, related_info, initial_posting_date, and last_updated_date. No fields were absent.

Source-derived regulatory summary

The text in this section is generated from the FDA source fields shown elsewhere on this page. It is regulatory information only — not medical advice — and adds no facts beyond the official record.

This record pertains to Dexmedetomidine Hydrochloride Injection, a product available in a presentation of 100 micrograms per milliliter (NDC 67457-251-02). It is manufactured by Mylan Institutional, a Viatris Company, and is related to anesthesia. The product was initially posted on April 10, 2020, and the last update was on August 20, 2026.

Regulatory context

The status of 'Current' indicates that the product is actively available in the market. The classification as 'Available' signifies that it can be obtained by healthcare providers or institutions for use. This information is regulatory in nature and does not imply any medical recommendations.

  • Drug shortage
  • Status: Current
  • Dexmedetomidine Hydrochloride Injection
  • Mylan Institutional, A Viatris Company

The summary was derived from the fields: generic_name, status, presentation, availability, company_name, related_info, initial_posting_date, and last_updated_date. No fields were absent.

Source-derived regulatory summary

The text in this section is generated from the FDA source fields shown elsewhere on this page. It is regulatory information only — not medical advice — and adds no facts beyond the official record.

This record pertains to Dexmedetomidine Hydrochloride Injection, a product available in a presentation of 200 ug/50 mL, identified by NDC 67457-924-50. The product is manufactured by Mylan Institutional, A Viatris Company, and is indicated for use in anesthesia. The initial posting date of this record is April 10, 2020, with the last update recorded on August 20, 2026.

Regulatory context

The status of 'Current' indicates that this product is actively marketed and available for use. The classification as 'Available' suggests that it can be obtained by healthcare providers or institutions. This information is regulatory in nature and does not imply any medical recommendations.

  • Drug shortage
  • Status: Current
  • Dexmedetomidine Hydrochloride Injection
  • Mylan Institutional, A Viatris Company

Fields used include generic_name, status, presentation, availability, company_name, related_info, initial_posting_date, and last_updated_date. No fields were absent.

Where to go next

Source & provenance

Official source
https://www.accessdata.fda.gov/scripts/drugshortages/
Source dataset
openFDA Drug Shortages API
Publication date
2020-04-10
Ingested
2026-08-22
Record hash
0602b43c21264469

Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.