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Animal NDC 64189-8502-0 Dexmedetomidine Hydrochloride

Animal Product Information

Field Name Field Value
Animal NDC Code 64189-8502-0
Proprietary Name Dexmedetomidine Hydrochloride What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Dexmedetomidine Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Grindeks Joint Stock Company
Product Type Bulk Ingredient - Animal Drug
Active Ingredient(s)
  • Dexmedetomidine Hydrochloride
Marketing Category BULK INGREDIENT What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Dexmedetomidine Hydrochloride Images

Dexmedetomidine Hydrochloride Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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).


Package Label.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


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.