DETOMIDINE HYDROCHLORIDE powder

Detomidine Hydrochloride by

Drug Labeling and Warnings

Detomidine 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 further manufacturing, processing, or repackaging, per 21 CFR 201.122

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

STORAGE AND HANDLING

Storage:  This product is a hygroscopic powder that should be stored in a dry place, protected from light. Keep container tightly closed. Recommend storage temperature 15° to  30°C (59° to 86°F).

PRINCIPAL DISPLAY PANEL

NDC Number: 64189-8601-0                        Country of Origin: Latvia

DETOMIDINE HYDROCHLORIDE

(Non-sterile, For Veterinary Use Only)

Cas Number: 90038-01-0                 VMF Number: 005-865

Lot Number:_______________         Release Date:____________

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

Storage:   This product is a hygroscopic powder that should be stored in a dry place, protected from light.  Keep container tightly closed.  REcommend storage temperature 15° to 30°C (59° to 86°F).

Caution: For further manufacturing, processing, or repackaging, per 21 CFR 201.122.  Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Grindex

Manufactured by: JSC GRINDEKS

53 Krustpils Street, Riga, LV-1057, Latvia

USA Exclusive Agent

GDL International, 1805 Oak Ridge Circle Suite 101

St. Joseph, MO 64506, USA

INGREDIENTS AND APPEARANCE

DETOMIDINE HYDROCHLORIDE 
detomidine hydrochloride powder

Product Information
Product Type		Item Code (Source)	NDC: 64189-8601
Route of Administration	NOT APPLICABLE

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DETOMIDINE HYDROCHLORIDE (UNII: 95K4LKB6QE) (DETOMIDINE - UNII:7N8K34P2XH)	DETOMIDINE HYDROCHLORIDE	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: 64189-8601-0	1 in 1 BAG
1		1000 g in 1 BAG
2	NDC: 64189-8601-1	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		06/30/2006

Labeler - GRINDEKS Joint Stock Company (644702888)

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