FDA.reportPublic FDA data

NDC 44567-602-01 - Dexmedetomidine

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
44567-602
Requested NDC
44567-602-01
Package NDCs from labels
44567-602-01, 44567-602-24
Manufacturer
WG Critical Care, LLC
Effective date
2026-06-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dexmedetomidine - WG Critical Care, LLCWG Critical Care, LLC2026-06-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44567-602-24Dexmedetomidine in Dextrose24 in 1 CARTONINJECTION2413
44567-602-24Dexmedetomidine in Dextrose50 mL in 1 BAGINJECTION5013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-602DEXMEDETOMIDINE INJECTION, SOLUTION, CONCENTRATE DEXMEDETOMIDINE IN DEXTROSE (DEXMEDETOMIDINE) INJECTION [WG CRITICAL CARE, LLC]8Current NDC, Legacy NDC, 2 package rows20250315_0d2710f2-ee47-4114-ab5c-8dca74cdcb8d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-602-24ML - Milliliter44567-60299081322-73b4-489e-b244-d2e8b6fecaa712018-12-13

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 3 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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.