FDA.reportPublic FDA data

Atipamezole Hydrochloride

Manufacturer
GRINDEKS Joint Stock Company
Effective date
2025-12-16
Label type
BULK INGREDIENT - ANIMAL DRUG
Version
3
Source
full-release
Hydrated at
2026-06-01 02:52:12

Label at a glance#

ProductAtipamezole Hydrochloride
Active ingredientATIPAMEZOLE HYDROCHLORIDE
Label structure3 sections

Storage and handling

Storage:   Preserve in an airtight container.  Store at 25°C (77°F), excursions permitted between 15° and  30°C (59° to 86°F).

Label contents#

Full prescribing information#

WARNINGS AND PRECAUTIONS SECTION

Caution:  For manufacturing, processing, or repackaging.

               Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

STORAGE AND HANDLING SECTION

Storage:  Preserve in an airtight container.  Store at 25°C (77°F), excursions permitted between 15° and  30°C (59° to 86°F).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC Number: 64189-0001-0                        Country of Origin: Latvia

ATIPAMEZOLE HYDROCHLORIDE

For Veterinary Use

Cas Number: 104075-48-1   

Lot Number:_______________         Release Date:____________

                                                          Retest Date:_____________ (Month, Year)

Storage:  Preserve in an airtight container.  Store at 25°C (77°F), excursions permitted between 15° and 30°C (59° to 86°F).

Caution:  For manufacturing, processing, or repackaging.  Federal law restricts this drug to use by or on the order of a licensed veterinarian.

                                                            Net Weight:_____________grams

Grindex

Manufactured by: JSC GRINDEKS

53 Krustpils Street, Riga, LV-1057, Latvia

64189-0001-0 Atipamezole HCl64189-0001-0 Atipamezole HCl

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64189-0001-0Atipamezole Hydrochloride1000 g in 1 BOTTLE, PLASTICPOWDER10003
64189-0001-0Atipamezole Hydrochloride1 in 1 BAGPOWDER13
64189-0001-1Atipamezole Hydrochloride5000 g in 1 BOTTLE, PLASTICPOWDER50003
64189-0001-1Atipamezole Hydrochloride1 in 1 BAGPOWDER13

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
64189-000164189-0001-0, 64189-0001-1

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
ATIPAMEZOLE HYDROCHLORIDE2W4279571XACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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