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Animal NDC 61133-5025-1 Tetroxy 25

Oxytetracycline Hcl

Animal Product Information

Field Name Field Value
Animal NDC Code 61133-5025-1
Proprietary Name Tetroxy 25 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 ANADA200146 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 25 Images

Tetroxy 25 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® 25

(oxytetracycline HCl)

Soluble Powder

CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

A broad spectrum ANTOBIOTIC

FOR CONTROL AND TREATMENT OF SPECIFIC DISEASES

IN POULTRY, CATTLE, SHEEP, SWINE AND HONEY BEES.

This packet contains 10 grams of oxytetracycline hydrochloride

For oral use in poultry, cattle, sheep, swine and honey bees.

FOR USE IN DRINKING WATER ONLY

NOT FOR USE IN LIQUID FEED SUPPLEMENTS

NOT FOR USE IN HUMANS

KEEP OUT OF REACH OF CHILDREN


Restricted Drug (California) - Use Only as Directed

ANADA 200-146, Approved by FDA


Contraindications



CONTRAINDICATION: Dusting of uncapped brood cells has been reported to cause death of larval honey bees. Do not dust uncapped brood cells.


Precautions



PRECAUTIONS: Use as sole source of oxytetracycline. Prepare fresh solutions every 24 hours.

Special Note: The concentration of drug required in medicated water must be adequate to compensate for variation in the age of the animal, feedconsumption rate and the environmental temperature and humidity, each of which affects water consumption.


Residue Warning



RESIDUE WARNING: Do not administer turkeys, cattle or sheep within 5 days of slaughter. Zero-day slaughter withdrawal in swine.  Do not administer to chickens or turkeys producing eggs for human consumption. Do not administer this product with milk replacers. Adminster 1 hour before or 2 hours after feeding milk or milk replacers. A milk discard period has not been estblished for this product in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. For honey bees, the drug should be fed early in the spring or fall and consumed by the bees before main honey flow begins to avoid contamination of production honey. Remove at least 6 weeks prior to main honey flow.


Storage And Handling



STORAGE: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F).


Package Label.Principal Display Panel




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