Animal NDC 76475-236-01 Chlortetracycline Hydrochloride

Animal Product Information

Field Name Field Value
Animal NDC Code 76475-236-01
Proprietary Name Chlortetracycline 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 Chlortetracycline 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 Quo Vademus
Product Type Prescription Animal Drug
Usage Information
    CHICKENSControl of infectious synovitis caused by M. synoviae - 200 to 400 mg chlortetracycline hydrochloride per gallon drinking water (5.0 - 13.4 mg/lb body weight per day). Control of chronic respiratory disease (CRD) and air sac infections caused by M. gallisepticum and E. coli - 400 to 800 mg chlortetracycline hydrochloride per gallon drinking water (10.0 - 26.8 mg/lb body weight per day).TURKEYSControl of infectious synovitis caused by M. synoviae - 400 mg chlortetracycline hydrochloride per gallon drinking water (3.2 - 16.8 mg/lb body weight per day). Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) - 25 mg chlortetracycline hydrochloride per pound body weight daily.SWINEControl and treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp. and bacterial pneumonia associated with Pasteurella spp., Actinobacillus pleuropneumonia, Klebsiella spp. - 10 mg chlortetracycline hydrochloride per pound body weight daily in divided doses for 3 to 5 days.
Active Ingredient(s)
  • Chlortetracycline 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 ANADA200236 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.

Chlortetracycline 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



Other



NDC 76475-236-01

CHLORTETRACYCLINE HYDROCHLORIDE SOLUBLE POWDER

Antibiotic 

For Use in Drinking Water of Chickens, Turkeys and Swine.

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

FOR VETERINARY USE ONLY

Restricted Drug(s) (California) Not for Human Use

Store at Controlled Room Temperature of 20° to 25°C (68° to 77°F). Brief exposure up to 40°C (104°F) may be tolerated.

Prepared fresh drinking water solutions daily.

For use in drinking water only.

Not for use in liquid feed supplements, milk or milk replacers.

Use as the sole source of drinking water.

KEEP OUT OF REACH OF CHILDREN

Safety Data Sheet (SDS) available.

Net Wt 725.8 g (25.6 oz)

Approved by FDA under ANADA # 200-236

Manufactured For:

Quo Vademus, LLC
Kenansville, NC 28349
[email protected] • 910-296-1632


Indications For Use And Dosage



CHICKENS

Control of infectious synovitis caused by M. synoviae - 200 to 400 mg chlortetracycline hydrochloride per gallon drinking water (5.0 - 13.4 mg/lb body weight per day). Control of chronic respiratory disease (CRD) and air sac infections caused by M. gallisepticum and E. coli - 400 to 800 mg chlortetracycline hydrochloride per gallon drinking water (10.0 - 26.8 mg/lb body weight per day).

TURKEYS

Control of infectious synovitis caused by M. synoviae - 400 mg chlortetracycline hydrochloride per gallon drinking water (3.2 - 16.8 mg/lb body weight per day). Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) - 25 mg chlortetracycline hydrochloride per pound body weight daily.

SWINE

Control and treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp. and bacterial pneumonia associated with Pasteurella spp., Actinobacillus pleuropneumonia, Klebsiella spp. - 10 mg chlortetracycline hydrochloride per pound body weight daily in divided doses for 3 to 5 days.


Warning



Withdraw 24 hours before slaughter of chickens, turkeys and five days for swine. Do not feed to chickens producing eggs for human consumption. For growing turkeys only.


Precautions



Prepare fresh drinking water solutions daily. In automatic watering systems, prepare fresh stock solutions every 6 hours. Solutions are not stable in galvanized containers; their use is not recommended. Drinking water solutions should not be stored at 40°C (104°F) for longer than 12 hours. Stock solutions should not be stored at 40°C (104°F) for longer than 3 hours. Use only against organisms sensitive to chlortetracycline. Use as the sole source of chlortetracycline. Do not mix in liquid feed supplements, milk or milk replacers. Administer 1 hour before or 2 hours after feeding with milk or milk replacers.


Directions For Use



Dissolve the contents of one packet of Chlortetracycline Hydrochloride Soluble Powder in four (4) gallons of water to prepare a stock solution, when metered at the rate of 1 oz of stock solution per gallon of drinking water, will deliver 200 mg chlortetracycline hydrochloride per gallon of drinking water. One level measuring teaspoon contains approximately 360 mg chlortetracycline hydrochloride which will treat 36 lbs (16 kg) of animal at 10 mg/lb for one day. Not to be used for more than 14 consecutive days in chickens and turkeys and five days in swine. The concentration of drug required in drinking water must be adjusted to provide a correct dosage in order to compensate for variations in the age of the animal, class of poultry, environmental temperature and humidity; each of which affects water consumption.

CHICKENS AND TURKEYS

Administer for 7 to 14 days. Medicate continuously at the first clinical signs of disease. The dosage range permitted provides for different levels based on the severity of the infection. As a generalization, 100 turkeys will drink one gallon of water per day for each week of age. Chickens will consume one half this amount.


Contents



This packet contains 102.4 grams of chlortetracycline hydrochloride (64 g/lb). Store at Controlled Room Temperature of 20° to 25°C (68° to 77°F). Brief exposure up to 40°C (104°F) may be tolerated.


Principal Display Panel  - 25.6 Ounce Packet



NDC 76475-236-01

CHLORTETRACYCLINE HYDROCHLORIDE SOLUBLE POWDER

Antibiotic

For Use in Drinking Water of Chickens, Turkeys and Swine.

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

FOR VETERINARY USE ONLY

Restricted Drug(s) (California) Not for Human Use

Store at Controlled Room Temperature of 20° to 25°C (68° to 77°F). Brief exposure up to 40°C (104°F) may be tolerated.

Prepared fresh drinking water solutions daily.

For use in drinking water only.

Not for use in liquid feed supplements, milk or milk replacers.

Use as the sole source of drinking water.

KEEP OUT OF REACH OF CHILDREN

Safety Data Sheet (SDS) available.

[QR Code]

Scan for SDS

Net Weight: 725.8 g (25.6 oz)

Approved by FDA under ANADA # 200-236

Manufactured For:

Quo Vademus, LLC
Kenansville, NC 28349
[email protected] • 910-296-1632


Principal Display Panel - 25 Pouch Carton Front Display Panel



NDC 76475-236-01

CHLORTETRACYCLINE HYDROCHLORIDE SOLUBLE POWDER

Antibiotic

For Use in Drinking Water of Chickens, Turkeys and Swine.

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

FOR VETERINARY USE ONLY

Restricted Drug(s) (California) Not for Human Use

Store at Controlled Room Temperature of 20° to 25°C (68° to 77°F). Brief exposure up to 40°C (104°F) may be tolerated.

For use in drinking water only.

Not for use in liquid feed supplements, milk or milk replacers.

Use as the sole source of drinking water.

KEEP OUT OF REACH OF CHILDREN

LOT NUMBER & EXPIRATION DATE

Net Weight: 25 x 725.8 grams (25.6 ounces)

Approved by FDA under ANADA # 200-236

Before using, read Safety Data Sheet (SDS) for the product.

Manufactured For:

Quo Vademus, LLC
Kenansville, NC 28349
[email protected] • 910-296-1632


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