Animal NDC 64189-8601-0 Detomidine Hydrochloride

Animal Product Information

Field Name Field Value
Animal NDC Code 64189-8601-0
Proprietary Name Detomidine 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 Detomidine 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)
  • Detomidine 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.

Detomidine Hydrochloride Images

Detomidine 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 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).


Package Label.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


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