Animal NDC 51429-091-01 Pennchlor 90g

Chlortetracycline Calcium

Animal Product Information

Field Name Field Value
Animal NDC Code 51429-091-01
Proprietary Name Pennchlor 90g 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
    Indications For UseUse Level of Chlortetracyclinelbs. of Pennchlor 90 G® per tonApproved by FDA under NADA # 138-935Pennchlor 90 G® is a registered trademark of Pharmgate Inc.ChickensFor Chickens: Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline. (Feed continuously for 7 - 14 days)100-200 g/ton1.11 – 2.22WARNING: DO NOT FEED TO CHICKENS PRODUCING EGGS FOR HUMAN CONSUMPTION. ZERO-DAY WITHDRAWAL PERIOD.For Chickens: 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 g/ton2.22 – 4.44WARNING: DO NOT FEED TO CHICKENS PRODUCING EGGS FOR HUMAN CONSUMPTION. ZERO-DAY WITHDRAWAL PERIOD.For Chickens: Reduction of mortality due to Escherichia coli infections susceptible to chlortetracycline (Feed for 5 days).500 g/ton5.55WARNING: DO NOT FEED TO CHICKENS PRODUCING EGGS FOR HUMAN CONSUMPTION. WITHDRAW 24 HOURS PRIOR TO SLAUGHTER. TurkeysFor Turkeys: Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline (Feed continuously for 7 - 14 days)200 g/ton2.22WARNING: DO NOT FEED TO TURKEYS PRODUCING EGGS FOR HUMAN CONSUMPTION. ZERO-DAY WITHDRAWAL PERIOD.For Turkeys: Control of hexamitiasis caused by Hexamita meleagrides susceptible to chlortetracycline. (Feed continuously for 7 - 14 days).400 g/ton4.44WARNING: DO NOT FEED TO TURKEYS PRODUCING EGGS FOR HUMAN CONSUMPTION. ZERO-DAY WITHDRAWAL PERIOD.For Turkeys: Turkey poults not over 4 weeks of age: Reduction of mortality due to paratyphoid caused by Salmonella typhimurium susceptible to chlortetracycline.400 g/ton4.44For Turkeys: Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to chlortetracycline. (Feed continuously for 7 - 14 days)25 mg/lb body weight/dayWARNINGS: DO NOT FEED TO TURKEYS PRODUCING EGGS FOR HUMAN CONSUMPTION. ZERO-DAY WITHDRAWAL PERIOD. SwineFor Swine: Reducing the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci susceptible to chlortetracycline.50-100 g/ton0.555 – 1.11For Breeding Swine: Control of leptospirosis (reducing the instances of abortions and shedding of leptospirae) caused by Leptospira pomona susceptible to chlortetracycline. (Feed continuously for not more than 14 days)400 g/ton4.44For Swine: Treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline. (Feed for not more than 14 days.)Feed approximately 400 g/t, varying with body weight and feed consumption to provide 10 mg/lb body weight/day.WARNING: ZERO-DAY WITHDRAWAL PERIOD. CALVES, BEEF CATTLE, AND NONLACTATING DAIRY CATTLE WARNING: A WITHDRAWAL PERIOD HAS NOT BEEN ESTABLISHED FOR THIS PRODUCT IN PRE-RUMINATNG CALVES. DO NOT USE IN CALVES TO BE PROCESSED FOR VEAL.For Growing Cattle (over 400 lbs.): For the reduction of the incidence of liver abscesses.70 mg/head/dayWARNING: ZERO-DAY WITHDRAWAL PERIOD.For Beef Cattle: For the control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline350 mg/head/dayWARNING: ZERO-DAY WITHDRAWAL PERIOD.For Beef Cattle (under 700 lbs.): Control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.350 mg/head/dayWARNING: ZERO-DAY WITHDRAWAL PERIOD.For Beef Cattle (over 700 lbs.): Control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.0.5 mg/ lb. body weight/dayWARNING: ZERO-DAY WITHDRAWAL PERIOD.For Calves, Beef, and Nonlactating Dairy Cattle: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline. (Treat for not more than 5 days)10 mg/lb. body weight/dayWARNING: ZERO-DAY WITHDRAWAL PERIOD. SheepFor Breeding Sheep: Reducing the incidence of (vibrionic) abortion caused by Campylobacter fetus infections susceptible to chlortetracycline.80 mg/head/dayWARNING: ZERO-DAY WITHDRAWAL PERIOD.
Active Ingredient(s)
  • Chlortetracycline Calcium
Inactive Ingredient(s)
  • CALCIUM CARBONATE (H0G9379FGK)
  • MINERAL OIL (T5L8T28FGP)
  • CALCIUM CARBONATE (H0G9379FGK)
  • MINERAL OIL (T5L8T28FGP)
Marketing Category NADA - 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 NADA138935 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.

Pennchlor 90g 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 FEED SUPPLEMENTS

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

Take Time Observe Directions


Description



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

Ingredients: Chlortetracycline, Calcium Carbonate, Roughage Products and Mineral Oil.

For Use in the Manufacture of Medicated Feeds.


Directions For Use



Indications For UseUse Level of Chlortetracyclinelbs. of Pennchlor 90 G® per ton
Approved by FDA under NADA # 138-935
Pennchlor 90 G® is a registered trademark of Pharmgate Inc.
Chickens
For Chickens: Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline. (Feed continuously for 7 - 14 days)100-200 g/ton1.11 – 2.22
WARNING: DO NOT FEED TO CHICKENS PRODUCING EGGS FOR HUMAN CONSUMPTION. ZERO-DAY WITHDRAWAL PERIOD.
For Chickens: 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 g/ton2.22 – 4.44
WARNING: DO NOT FEED TO CHICKENS PRODUCING EGGS FOR HUMAN CONSUMPTION. ZERO-DAY WITHDRAWAL PERIOD.
For Chickens: Reduction of mortality due to Escherichia coli infections susceptible to chlortetracycline (Feed for 5 days).500 g/ton5.55
WARNING: DO NOT FEED TO CHICKENS PRODUCING EGGS FOR HUMAN CONSUMPTION. WITHDRAW 24 HOURS PRIOR TO SLAUGHTER.
 
Turkeys
For Turkeys: Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline (Feed continuously for 7 - 14 days)200 g/ton2.22
WARNING: DO NOT FEED TO TURKEYS PRODUCING EGGS FOR HUMAN CONSUMPTION. ZERO-DAY WITHDRAWAL PERIOD.
For Turkeys: Control of hexamitiasis caused by Hexamita meleagrides susceptible to chlortetracycline. (Feed continuously for 7 - 14 days).400 g/ton4.44
WARNING: DO NOT FEED TO TURKEYS PRODUCING EGGS FOR HUMAN CONSUMPTION. ZERO-DAY WITHDRAWAL PERIOD.
For Turkeys: Turkey poults not over 4 weeks of age: Reduction of mortality due to paratyphoid caused by Salmonella typhimurium susceptible to chlortetracycline.400 g/ton4.44
For Turkeys: Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to chlortetracycline. (Feed continuously for 7 - 14 days)25 mg/lb body weight/day
WARNINGS: DO NOT FEED TO TURKEYS PRODUCING EGGS FOR HUMAN CONSUMPTION. ZERO-DAY WITHDRAWAL PERIOD.
 
Swine
For Swine: Reducing the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci susceptible to chlortetracycline.50-100 g/ton0.555 – 1.11
For Breeding Swine: Control of leptospirosis (reducing the instances of abortions and shedding of leptospirae) caused by Leptospira pomona susceptible to chlortetracycline. (Feed continuously for not more than 14 days)400 g/ton4.44
For Swine: Treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline. (Feed for not more than 14 days.)Feed approximately 400 g/t, varying with body weight and feed consumption to provide 10 mg/lb body weight/day.
WARNING: ZERO-DAY WITHDRAWAL PERIOD.
 
CALVES, BEEF CATTLE, AND NONLACTATING DAIRY CATTLE WARNING: A WITHDRAWAL PERIOD HAS NOT BEEN ESTABLISHED FOR THIS PRODUCT IN PRE-RUMINATNG CALVES. DO NOT USE IN CALVES TO BE PROCESSED FOR VEAL.
For Growing Cattle (over 400 lbs.): For the reduction of the incidence of liver abscesses.70 mg/head/day
WARNING: ZERO-DAY WITHDRAWAL PERIOD.
For Beef Cattle: For the control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline350 mg/head/day
WARNING: ZERO-DAY WITHDRAWAL PERIOD.
For Beef Cattle (under 700 lbs.): Control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.350 mg/head/day
WARNING: ZERO-DAY WITHDRAWAL PERIOD.
For Beef Cattle (over 700 lbs.): Control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.0.5 mg/ lb. body weight/day
WARNING: ZERO-DAY WITHDRAWAL PERIOD.
For Calves, Beef, and Nonlactating Dairy Cattle: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline. (Treat for not more than 5 days)10 mg/lb. body weight/day
WARNING: ZERO-DAY WITHDRAWAL PERIOD.
 
Sheep
For Breeding Sheep: Reducing the incidence of (vibrionic) abortion caused by Campylobacter fetus infections susceptible to chlortetracycline.80 mg/head/day
WARNING: ZERO-DAY WITHDRAWAL PERIOD.

Principal Display Panel - 22.68 Kg Bag Label



Pennchlor® 90 G™

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.

Net wt. 50 LB (22.68 Kg)

Pharmgate
ANIMAL HEALTH


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