DEXMEDETOMIDINE HYDROCHLORIDE powder

Dexmedetomidine Hydrochloride by

Drug Labeling and Warnings

Dexmedetomidine Hydrochloride by is a Other medication manufactured, distributed, or labeled by GRINDEKS Joint Stock Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

Caution:  For manufacturing, processing, or repackaging, per 21 CFR 201.122.

STORAGE AND HANDLING

Storage:  Hygroscopic.  Should be stored in a airtight container. Recommended storage temperature is from 15° to  30°C (59° to 86°F).

PRINCIPAL DISPLAY PANEL

NDC Number: 64189-8502-1                        Country of Origin: Latvia

DEXMEDETOMIDINE HYDROCHLORIDE

(Non-sterile, For Veterinary Use Only)

Cas Number: 145108-58-3              VMF Number: 006-249

Lot Number:_______________         Release Date:____________

Net Weight:____________gram         Retest Date:_____________ (Month, Year)

Storage:  Hygroscopic.  Should be stored in a airtight container.  Recommended storage temperature is from  15° to 30°C (59° to 86°F).

Caution:  For manufacturing, processing, or repackaging, per 21 CFR 201.122.

Grindex

Manufactured by: JSC GRINDEKS

53 Krustpils Street, Riga, LV-1057, Latvia

INGREDIENTS AND APPEARANCE

DEXMEDETOMIDINE HYDROCHLORIDE 
dexmedetomidine hydrochloride powder

Product Information
Product Type		Item Code (Source)	NDC: 64189-8502
Route of Administration	NOT APPLICABLE

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXMEDETOMIDINE HYDROCHLORIDE (UNII: 1018WH7F9I) (DEXMEDETOMIDINE - UNII:67VB76HONO)	DEXMEDETOMIDINE	1 g  in 1 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64189-8502-0	1 in 1 BAG
1		1000 g in 1 BAG
2	NDC: 64189-8502-1	1 in 1 BAG
2		5000 g in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
bulk ingredient		05/11/2018

Labeler - GRINDEKS Joint Stock Company (644702888)

Establishment
Name	Address	ID/FEI	Business Operations
GRINDEKS Joint Stock Company		644702888	api manufacture