FDA.reportPublic FDA data

Detomidine Hydrochloride

Manufacturer
AMERICAN PHARMACEUTICAL INGREDIENTS LLC
Effective date
2014-04-25
Label type
BULK INGREDIENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:47:55

Label at a glance#

ProductDetomidine Hydrochloride
Active ingredientDetomidine Hydrochloride
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58597-8219-3Detomidine Hydrochloride10 g in 1 BOTTLEPOWDER101
58597-8219-4Detomidine Hydrochloride25 g in 1 BOTTLEPOWDER251
58597-8219-6Detomidine Hydrochloride100 g in 1 BOTTLEPOWDER1001
58597-8219-7Detomidine Hydrochloride500 g in 1 BOTTLEPOWDER5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58597-8219DETOMIDINE HYDROCHLORIDE POWDER [AMERICAN PHARMACEUTICAL INGREDIENTS LLC]14 package rows20140426_d0d2272d-d25b-4298-915d-4f16b1417877.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Detomidine HydrochlorideACTIVE INGREDIENT95K4LKB6QE1
Detomidine HydrochlorideACTIVE MOIETY95K4LKB6QE1

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58597-821958597-8219-3, 58597-8219-4, 58597-8219-6, 58597-8219-7

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
Detomidine Hydrochloride95K4LKB6QEACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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