Animal NDC 57561-300-09 Tetra-bac 324

Tetracycline Hydrochloride

Animal NDC Product Code 57561-300-09

Field Name Field Value
Animal NDC Code 57561-300-09
Proprietary Name Tetra-bac 324 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 Tetracycline 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 Agri Laboratories, Ltd.
Product Type Prescription Animal Drug
Active Ingredient(s)
  • Tetracycline 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 ANADA200049 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.

Tetra-bac 324 Animal Product Label Images

Tetra-bac 324 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.

Product Labeling Index

Indications & Usage

TETRACYCLINE HYDROCHLORIDE SOLUBLE POWDER 324 ANTIBIOTICCAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.Each pound contains 324g of tetracycline hydrochloride.ANADA 200-049, Approved by FDAFOR ANIMAL USE ONLYKEEP OUT OF REACH OF CHILDRENRestricted Drug (California)-Use Only as DirectedINDICATIONSFor use in the control and treatment of the following conditions in swine, calves and poultry.SWINE AND CALVES:Control and treatment of bacterial enteritis (scours) caused byEscherichia coli and bacterial pneumonia associated with Actinobacillus pleuropneumoniae, Pasteurella spp., Klebsiella spp. susceptible to tetracycline.CHICKENS: Control of chronic respiratory disease (CRD air sac disease) caused by Mycoplasma gallisepticum and Escherichia coli; infectious synovitis caused by Mycoplasma synoviae susceptible to tetracycline.RECOMMENDED DOSAGE LEVEL: CRD air sac disease; 400-800 mg tetracycline hydrochloride per gallon of drinking water. Infectious synovitis; 200-400 mg tetracycline hydrochloride per gallon of drinking water. TURKEYS: Control of infectious synovitis caused by Mycoplasma synoviae, bluecomb (transmissible enteritis, coronaviral enteritis) complicated by organisms susceptible to tetracycline. RECOMMENDED DOSAGE LEVEL: Infectious synovitis; 400 mg tetracycline hydrochloride per gallon of drinking water. Bluecomb; 25 mg/lb body weight of tetracycline hydrochloride per day in divided doses.

Residue Warning

Do not slaughter swine for food purposes within 4 days of treatment.  Do not slaughter cattle for food purposes within 5 days of treatment.  Do not slaughter poultry for food within 4 days of treatment.  Not for use in poultry producing eggs for human consumption.  A withdrawal period has not been established for this product in pre-ruminating calves.  Do not use in calves to be processed for veal.

Caution

Use as sole source of tetracycline.  Not to be used in swine or calves for more than 5 days.  Not to be used in chickens or turkeys for more than 14 consecutive days.  When using plastic or stainless steel waterers or automatic medicators, prepare fresh solution every 24 hours.  When used in galvanized waterers, prepare fresh solution every 12 hours.  If condition does not improve within 2 to 3 days, consult your veterinarian.

Dosage And Administration

Administer TETRA-BAC 324 in the drinking water of swine and calves for 3 to 5 days at a drug level of tetracycline hydrochloride per gallon to provide approximately 10 mg/lb of body weight, per day in divided doses.  In turkeys, for bluecomb only, administer in the drinking water for 7 - 14 days at a drug level of 25 mg/lb of body weight, per day in divided doses.MIXING DIRECTIONS FOR SWINE, CALVES AND TURKEYS:  Add one level scoop (1.26 oz.) to 250 mL (8.5 oz) of warm water and dissolve.  This will provide stock solution of 100 mg/mL of tetracycline hydrochloride.  FOR TURKEYS ONLY:  This stock solution when metered at approximately 1 oz., per gallon, will provide drinking water containing 2957 mg of tetracycline hydrochloride activity per gallon. Calves: Calves may be treated individually by administering 5 mL (1 measuring teaspoonful) to stock solution twice daily for each 100 lbs body weight as a drench or by dose syringe. CHICKENS AND TURKEYS:  To arrive at the recommended dosages, prepare stock solutions as follows and meter into the drinking water at 1 oz per gallon.    200 mg/gallon - dissolve 1 level scoop (1.26 oz) in 3785 mL warm water (1 gallon) - Provides 128 gallons medicated drinking water.    400 mg/gallon - dissolve 1 level scoop (1.26 oz) in 1892 mL warm water (0.5 gallon) - Provides 64 gallons medicated drinking water.    800 mg/gallon - dissolve 1 level scoop (1.26 oz) in 946 mL warm water (0.25 gallon) - Provides 32 gallons medicated drinking water.NOTE:  The concentration of the drug required in medicated water must be adequate to compensate for variation in the age of the animal, feed consumption and the environmental temperature and humidity, each of which affects water consumption. The contents of this container (2 lb) will provide sufficient drug to treat 64,800 total pounds of swine or calves for a single day at the recommended dosage level of 10 mg/lb of body weight in divided doses.  The same container will treat 25,920 lb of turkeys when supplied at 25 mg/lb.

Storage And Handling

Store at 59°-86°F

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