Animal NDC 51429-092-05 Deracin 90 Meal

Chlortetracycline Calcium

Animal Product Information

Field Name Field Value
Animal NDC Code 51429-092-05
Proprietary Name Deracin 90 Meal 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 Calcium 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 Pharmgate Animal Health
Product Type Vfd Type A Medicated Article Animal Drug
Usage Information
    Use Directions: Mix sufficient Deracin® 90 Meal Type A Medicated Article to supply desired concentration of chlortetracycline per ton with part of the feed ingredients to make a preblend. Add the remainder of the ingredients and mix thoroughly. For specific use levels, see Indications for Use.Mixing directions:Level desired grams per tonAmount of medicated Article per tonIt is recommended that 1 pound 2 ounces of Deracin 90 Meal Type A Medicated Article be diluted with 2 pounds 14 ounces of one of the feed ingredients to form a 4 pound working premix. Use 2 pounds of the working premix to make a preblend (see Use Directions) for a Type C feed containing 50g chlortetracycline/ton of feed.509 oz1001lb 2 oz2002 lb 4 oz4004 lb 8 oz5005 lb 9 ozINDICATIONS FOR USEChlortetracycline mg per lb body weight per dayCattleBeef cattle (over 700 lbs.): Control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.0.5Beef and Non-Lactating Dairy Cattle: As an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline. For use in free-choice feeds. A medicated feed mill license is required when the free-choice feed is manufactured using a proprietary formula and/or specifcations. Free-choice feed formulations must be FDA approved.0.5-2.0Calves, Beef, and Nonlactating Dairy Cattle: Treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline. Feed for not more than 5 days. The appropriate amount of Deracin ® containing feed supplement may be mixed in the cattle's daily ration or administered as a top dress. If the Deracin ® containing feed supplement is administered as a top dress, it must be spread uniformly on top of the ration and sufficient space must be provided so that all cattle can eat at the same time.10SwineControl of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline. Treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline. (Note: This drug level is equivalent to approximately 400 grams per ton, depending on feed consumption and body weight). Feed for not more than 14 days.10TurkeysControl of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to chlortetracycline. Feed continuously for 7 - 14 days.25INDICATIONS FOR USEmg per head per dayCattleGrowing cattle (over 400 lbs.): For the reduction of the incidence of liver abscesses.70Beef Cattle and Dairy Replacement Heifers: Control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline350Beef cattle (under 700 lbs.): Control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.350SheepBreeding Sheep: Reduction in the incidence of (vibrionic) abortions caused by Campylobacter fetus infection susceptible to chlortetracycline.80INDICATIONS FOR USEIn complete feed Chlortetracycline g per tonSwineReduction in the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci susceptible to chlortetracycline50-100Breeding Swine: Control of leptospirosis (reducing the instances of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to chlortetracycline. Feed continuously for not more than 14 days.400DucksControl and treatment of fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline. Feed in complete ration to provide from 8 to 28 mg per pound of body weight per day depending upon age and severity of disease. Feed for not more than 21 days.200-400ChickensControl of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline. Feed continuously for 7 - 14 days.100-200Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to chlortetracycline. Feed continuously for 7 - 14 days.200-400Reduction of mortality due to Escherichia coli infections susceptible to chlortetracycline. Feed for 5 days.500TurkeysControl of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline Feed continuously for 7 - 14 days.200Control of hexamitiasis caused by Hexamita meleagrides susceptible to chlortetracycline. Feed continuously for 7 - 14 days.400Turkey poults not over 4 weeks of age: Reduction of mortality due to paratyphoid caused by Salmonella typhimurium susceptible to chlortetracycline.400INDICATIONS FOR USEmg per g feedPsittacine birdsWarning: Psittacosis, avian chlamydiosis, or ornithosis is a reportable communicable disease, transmissible between wild and domestic birds, other animals and man. Contact appropriate public health and regulatory officials.Caution: Aspergillosis may occur following prolonged treatment.Treatment of psittacine birds (parrots, macaws, cockatoos) suspected or known to be infected with psittacosis caused by Chlamydia psittaci sensitive to chlortetracycline. Feed continuously for 45 days. Each bird should consume an amount of medicated feed equal to one-fifth of this body weight daily. During treatment, parrots, macaws, and cockatoos should be kept individually or in pairs in clean cages.10
Active Ingredient(s)
  • Chlortetracycline Calcium
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 ANADA200510 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.

Deracin 90 Meal 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



Chlortetracyline

Type A Medicated Article

CAUTION: For use in Dry Feeds ONLY. NOT FOR USE IN LIQUID MEDICATED FEEDS.

Approved by FDA under ANADA # 200-510

Marketed by:
Pharmgate Animal Health, LLC
14040 Industrial Road
Omaha, NE 68144

Take TimeObserve Directions


Description



Active Drug Ingredients: Chlortetracycline as Chlortetracycline Calcium Complex Equivalent to 90 grams Chlortetracycline Hydrochloride/lb.

Ingredients: Dried Streptomyces aureofaciens fermentation product in a carrier suitable for incorporation in feed.

For Use in the Manufacture of Medicated Feeds.


Veterinary Indications



Use Directions: Mix sufficient Deracin® 90 Meal Type A Medicated Article to supply desired concentration of chlortetracycline per ton with part of the feed ingredients to make a preblend. Add the remainder of the ingredients and mix thoroughly. For specific use levels, see Indications for Use.
Mixing directions:
Level desired grams per tonAmount of medicated Article per ton

It is recommended that 1 pound 2 ounces of Deracin 90 Meal Type A Medicated Article be diluted with 2 pounds 14 ounces of one of the feed ingredients to form a 4 pound working premix. Use 2 pounds of the working premix to make a preblend (see Use Directions) for a Type C feed containing 50g chlortetracycline/ton of feed.

509 oz
1001lb 2 oz
2002 lb 4 oz
4004 lb 8 oz
5005 lb 9 oz
INDICATIONS FOR USEChlortetracycline mg per lb body weight per day
Cattle
Beef cattle (over 700 lbs.): Control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.0.5
Beef and Non-Lactating Dairy Cattle: As an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline. For use in free-choice feeds. A medicated feed mill license is required when the free-choice feed is manufactured using a proprietary formula and/or specifcations. Free-choice feed formulations must be FDA approved.0.5-2.0
Calves, Beef, and Nonlactating Dairy Cattle: Treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline. Feed for not more than 5 days. The appropriate amount of Deracin ® containing feed supplement may be mixed in the cattle's daily ration or administered as a top dress. If the Deracin ® containing feed supplement is administered as a top dress, it must be spread uniformly on top of the ration and sufficient space must be provided so that all cattle can eat at the same time.10
Swine
Control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline. Treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline. (Note: This drug level is equivalent to approximately 400 grams per ton, depending on feed consumption and body weight). Feed for not more than 14 days.10
Turkeys
Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to chlortetracycline. Feed continuously for 7 - 14 days.25
INDICATIONS FOR USEmg per head per day
Cattle
Growing cattle (over 400 lbs.): For the reduction of the incidence of liver abscesses.70
Beef Cattle and Dairy Replacement Heifers: Control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline350
Beef cattle (under 700 lbs.): Control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.350
Sheep
Breeding Sheep: Reduction in the incidence of (vibrionic) abortions caused by Campylobacter fetus infection susceptible to chlortetracycline.80
INDICATIONS FOR USEIn complete feed Chlortetracycline g per ton
Swine
Reduction in the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci susceptible to chlortetracycline50-100
Breeding Swine: Control of leptospirosis (reducing the instances of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to chlortetracycline. Feed continuously for not more than 14 days.400
Ducks
Control and treatment of fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline.
Feed in complete ration to provide from 8 to 28 mg per pound of body weight per day depending upon age and severity of disease. Feed for not more than 21 days.
200-400
Chickens
Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline. Feed continuously for 7 - 14 days.100-200
Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to chlortetracycline. Feed continuously for 7 - 14 days.200-400
Reduction of mortality due to Escherichia coli infections susceptible to chlortetracycline. Feed for 5 days.500
Turkeys
Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline Feed continuously for 7 - 14 days.200
Control of hexamitiasis caused by Hexamita meleagrides susceptible to chlortetracycline. Feed continuously for 7 - 14 days.400
Turkey poults not over 4 weeks of age: Reduction of mortality due to paratyphoid caused by Salmonella typhimurium susceptible to chlortetracycline.400
INDICATIONS FOR USEmg per g feed
Psittacine birds
Warning: Psittacosis, avian chlamydiosis, or ornithosis is a reportable communicable disease, transmissible between wild and domestic birds, other animals and man. Contact appropriate public health and regulatory officials.
Caution: Aspergillosis may occur following prolonged treatment.
Treatment of psittacine birds (parrots, macaws, cockatoos) suspected or known to be infected with psittacosis caused by Chlamydia psittaci sensitive to chlortetracycline. Feed continuously for 45 days. Each bird should consume an amount of medicated feed equal to one-fifth of this body weight daily. During treatment, parrots, macaws, and cockatoos should be kept individually or in pairs in clean cages.10

Warnings



Withdrawal Periods and Residue Warning:

No withdrawal period is required when used according to label. This drug is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in preruminating calves.
Do not use In calves to be processed for veal.
Do not feed to ducks or turkeys producing eggs for human consumption.


Storage And Handling



Store below 25°C (77°F), excursions permitted to 40°C (104°F). Tightly reseal opened bags.


Principal Display Panel - 22.68 Kg Bag Label



Deracin® 90 Meal

Chlortetracycline

Type A Medicated Article

CAUTION: Federal law restricts medicated feed
containing this veterinary feed directive (VFD) drug
to use by or on the order of a licensed veterinarian.

See mixing directions, claims, cautions
and warnings on back.

Restricted Drug (California) - Use Only as Directed.
Not For Human Use.
Keep out of reach of children.

Net wt. 50 LB (22.68 Kg)


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