FDA.reportPublic FDA data

Xylazine Hydrochloride

Manufacturer
AMERICAN PHARMACEUTICAL INGREDIENTS LLC
Effective date
2014-05-02
Label type
BULK INGREDIENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:47:57

Label at a glance#

ProductXylazine Hydrochloride
Active ingredientXylazine 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
58597-8582-6Xylazine Hydrochloride100 g in 1 BOTTLEPOWDER1001
58597-8582-8Xylazine Hydrochloride1000 g in 1 BOTTLEPOWDER10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58597-8582XYLAZINE HYDROCHLORIDE POWDER [AMERICAN PHARMACEUTICAL INGREDIENTS LLC]12 package rows20140503_0439a803-bac5-425f-a73f-8101c79593e2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Xylazine HydrochlorideACTIVE INGREDIENTNGC3S0882S1
Xylazine HydrochlorideACTIVE MOIETYNGC3S0882S1

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
58597-858258597-8582-6, 58597-8582-8

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
Xylazine HydrochlorideNGC3S0882SACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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