Label: DEXMEDETOMIDINE HYDROCHLORIDE powder
- NDC Code(s): 64189-8502-0, 64189-8502-1
- Packager: GRINDEKS Joint Stock Company
- Category: BULK INGREDIENT - ANIMAL DRUG
Drug Label Information
Updated December 21, 2021
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- WARNINGS AND PRECAUTIONS
- STORAGE AND HANDLING
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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
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INGREDIENTS AND APPEARANCE
DEXMEDETOMIDINE HYDROCHLORIDE
dexmedetomidine hydrochloride powderProduct 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