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Animal NDC 61133-5010-3 Tetroxy Hca

Oxytetracycline Hcl

Animal Product Information

Field Name Field Value
Animal NDC Code 61133-5010-3
Proprietary Name Tetroxy Hca 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 Oxytetracycline Hcl 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 Bimeda, Inc.
Product Type Prescription Animal Drug
Active Ingredient(s)
  • Oxytetracycline Hydrochloride
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION 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.
FDA Application Number ANADA200144 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Tetroxy Hca Images

Tetroxy Hca 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



Description



Tetroxy® HCA-1400
(oxytetracycline hydrochloride soluble powder)
Antibiotic
CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

This packet contains 512 g of oxytetracycline hydrochloride and will make:
2560 gallons (9690 liters) containing 200 mg oxytetracycline hydrochloride per gallon
1280 gallons (4845 liters) containing 400 mg oxytetracycline hydrochloride per gallon
640 gallons (2422 liters) containing 800 mg oxytetracycline hydrochloride per gallon
This packet will treat 51,200 lbs of swine.
This packet will treat 20,480 lbs of turkey at 25 mg/lb body weight.

For Use in Drinking Water Only
Not For Use in Liquid Medicated Feeds
Not For Use in Humans
Keep Out of Reach of Children
HAZARDOUS REMEDY
See back panel for instructions.
Approved by FDA under ANADA # 200-144

Net Weight: 3.09 lb (1400 g)


Precautions



CAUTION: Use as the sole source of oxytetracycline. Not to be used for more than 5 consecutive days in swine or 14 consecutive days in chickens and turkeys.


Residue Warning



WARNING: Do not feed to birds producing eggs for human consumption.


Storage And Handling



RECOMMENDED PACKET STORAGE CONDITIONS: Store between 20°C - 25°C (68°F - 77°F) with excursions permitted between 15°C - 40°C (59°F - 104°F).

CONTACT INFORMATION: To report adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae


Package Label.Principal Display Panel




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