FDA.reportPublic FDA data

NDC 86101-061 - DEXMEDETOMIDINE HYDROCHLORIDE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
86101-061
Package NDCs from labels
86101-061-41
Manufacturer
FELIX PHARMACEUTICALS PRIVATE LIMITED
Effective date
2025-09-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DEXMEDETOMIDINE HYDROCHLORIDE - FELIX PHARMACEUTICALS PRIVATE LIMITEDFELIX PHARMACEUTICALS PRIVATE LIMITED2025-09-16Prescription Animal Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86101-061-41DEXMEDETOMIDINE HYDROCHLORIDE1 in 1 CARTONINJECTION, SOLUTION11
86101-061-41DEXMEDETOMIDINE HYDROCHLORIDE10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION101

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 2 of 2 · 38 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DexmedetomidineDEXMEDETOMIDINEProPharma Distribution42cbeadf-fea3-d2ae-e063-6394a90ad5492025-12-18Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
Dexmedetomidine Hydrochloride in Sodium ChlorideDEXMEDETOMIDINE HYDROCHLORIDEPrecision Dose, Inc.e9d5c989-ebf6-4377-9c6e-7aef848a03a12025-12-15Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
DEXMEDETOMIDINEDEXMEDETOMIDINEProPharma Distribution42dab90e-68c1-bed1-e063-6294a90a4b0c2025-11-05Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEProPharma Distribution42caba25-dd87-040c-e063-6294a90a7a122025-11-04Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEFresenius Kabi USA, LLCc1b8eb58-596b-481d-beb6-ba9d2237abf42025-09-22Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDESagent Pharmaceuticals65885aef-faaf-4dec-a180-9a657f738bbc2025-06-26Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
DexmedetomidineDEXMEDETOMIDINEAccord Healthcare Inc.2b9881f0-4a66-660f-e054-00144ff88e882025-02-11Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDESomerset Therapeutics, LLC649e777b-9b30-4f1e-9fb9-6bba575809762024-09-26Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEWilshire Pharmaceuticals, Inc.f550d2ba-49ac-4a3b-95db-692b468af4792024-08-14Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
DexmedetomidineDEXMEDETOMIDINEMedical Purchasing Solutions, LLC12ef0602-bf07-6ddd-e063-6294a90a23c32024-03-05Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEPar Health USA, LLC1ee59985-4c1d-48f7-b8f9-5584c2d55e082024-02-01Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
Dexmedetomidine Hydrochloride in 0.9% Sodium ChlorideDEXMEDETOMIDINE HYDROCHLORIDESagent Pharmaceuticalsa99335d0-1e87-4180-bde3-cbb12bf91a522023-10-06Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEMedical Purchasing Solutions, LLCa268e759-9a3e-1d7b-e053-2a95a90a335b2023-06-01Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
Dexmedetomidine hydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEMedical Purchasing Solutions, LLCa2666c50-3b55-1380-e053-2a95a90aea582023-06-01Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEMedical Purchasing Solutions, LLC6937235f-ea25-4950-e053-2991aa0a9b742023-05-23Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
Dexmedetomidine HClDEXMEDETOMIDINE HCLMedical Purchasing Solutions, LLCada70a68-3e52-4b94-e053-2995a90aa1e02023-05-03Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEDr.Reddy's Laboratories Incd174c19d-56f1-4ef4-087c-23c26db8e40b2022-07-01Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDESun Pharmaceuticals Industries, Inc.4fe788bc-4ad1-4b32-83d3-dcbfcd8429aa2018-08-20Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I

Reported adverse events (FAERS/openFDA)#

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