FDA.reportPublic FDA data

Dexmedetomidine HCl

Manufacturer
AX Pharmaceutical Corp
Effective date
2023-02-02
Label type
BULK INGREDIENT - ANIMAL DRUG
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:38:24

Label at a glance#

ProductDexmedetomidine HCl
Active ingredientDEXMEDETOMIDINE HYDROCHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

Dexmedetomidine HCl

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73377-08373377-083-01, 73377-083-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXMEDETOMIDINE HYDROCHLORIDE1018WH7F9IACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEPiramal Critical Care Incc958aeb4-69ce-c3e2-e053-2a95a90a6d8d2026-07-28Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
PrecedexDEXMEDETOMIDINE HYDROCHLORIDEHospira, Inc.92b7ddaa-e45a-4b64-a802-bb5df8771dd62026-06-17Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
PrecedexDEXMEDETOMIDINE HYDROCHLORIDEHospira, Inc.4419162d-81d4-49bd-96de-1729440bdb742026-06-09Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare Corporation7d057255-22a1-4b69-ad7c-7337fac8e9932026-05-29Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEAmneal Pharmaceuticals LLCeb1ba463-ab42-4f49-9ebe-3ad5af1083262026-05-28Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDECIVICA, INC.1faf1ac8-ff9b-4ed9-b562-06dab971173a2026-05-22Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
PRECEDEXDEXMEDETOMIDINE HYDROCHLORIDEHenry Schein, Inc.9eb336de-5fa5-4b46-b40b-a7ca5a0864bd2026-05-21Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEGland Pharma Limitedf307de7e-a9ab-4734-abb7-66b4e112bc512026-05-20Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
PrecedexDEXMEDETOMIDINE HYDROCHLORIDEHospira, Inc.548a88c0-afda-427e-75ac-5af0cfa2224c2026-05-20Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEMylan Institutional LLCf140de5a-f13d-46b4-a742-049c63e474f52026-05-20Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEFresenius Kabi USA, LLC1896a96e-25f8-494e-9a96-6463b52fb1022026-01-23Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine Hydrochloride in Sodium ChlorideDEXMEDETOMIDINE HYDROCHLORIDEPrecision Dose, Inc.e9d5c989-ebf6-4377-9c6e-7aef848a03a12025-12-15Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEFresenius Kabi USA, LLCc1b8eb58-596b-481d-beb6-ba9d2237abf42025-09-22Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDESagent Pharmaceuticals65885aef-faaf-4dec-a180-9a657f738bbc2025-06-26Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDESomerset Therapeutics, LLC649e777b-9b30-4f1e-9fb9-6bba575809762024-09-26Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEWilshire Pharmaceuticals, Inc.f550d2ba-49ac-4a3b-95db-692b468af4792024-08-14Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEPar Health USA, LLC1ee59985-4c1d-48f7-b8f9-5584c2d55e082024-02-01Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine Hydrochloride in 0.9% Sodium ChlorideDEXMEDETOMIDINE HYDROCHLORIDESagent Pharmaceuticalsa99335d0-1e87-4180-bde3-cbb12bf91a522023-10-06Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEMedical Purchasing Solutions, LLCa268e759-9a3e-1d7b-e053-2a95a90a335b2023-06-01Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine hydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEMedical Purchasing Solutions, LLCa2666c50-3b55-1380-e053-2a95a90aea582023-06-01Warnings, Adverse reactionsName fallback
generic name: DEXMEDETOMIDINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.