Label: DETOMIDINE HYDROCHLORIDE powder
- NDC Code(s): 64189-8601-0, 64189-8601-1
- Packager: GRINDEKS Joint Stock Company
- Category: BULK INGREDIENT - ANIMAL DRUG
Drug Label Information
Updated December 21, 2021
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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
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INGREDIENTS AND APPEARANCE
DETOMIDINE HYDROCHLORIDE
detomidine hydrochloride powderProduct 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