Animal NDC 51429-064-01 Pennchlor 64
Chlortetracycline Hydrochloride
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 51429-064-01 |
| Proprietary Name | Pennchlor 64 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 | Pharmgate Animal Health |
| Product Type | Prescription Animal Drug |
| Usage Information |
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| Active Ingredient(s) |
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| 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 | ANADA200295 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. |
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Pennchlor 64 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
Residue Warning
RESIDUE WARNINGS
Do not administer to chickens within 24 hours of slaughter. Do not use in laying chickens. Do not administer to growing turkeys within 24 hours of slaughter. Zero day withdrawal in swine. Do not administer to cattle within 24 hours of slaughter. Do not use in lactating dairy cattle. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal.
Dosage & Administration
GENERAL INFORMATION ON DOSAGE
Dosages in terms of packets per 512 gallons are based on stated dosages per unit of body weight and average water consumption of the species. Weather conditions, ambient temperature, humidity, age, class of livestock and other factors may affect consumption and, except where calves are drenched, the unit dosage should be used as a guide to effective use in drinking water. Animals must actually consume enough medicated water to provide the desired therapeutic dose under the conditions that prevail.
Precautions
Use as the sole source of chlortetracycline. Prepare fresh solutions daily. When used in plastic or stainless steel waterers or automatic waterers, prepare fresh solutions every 24 hours. This product has not been demonstrated to provide adequate stability in galvanized waterers. Stability loss may reduce effectiveness of the product. Do not administer in milk or milk replacers. When feeding milk or milk replacers, administration one hour before or two hours after feeding is recommended.
Veterinary Indications
Indications and Directions For Use
| Chickens | Dose |
|---|---|
| Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline. | 200-400 mg/gal (1-2 packets/512 gallons). This is equivalent to ¼ - ½ oz of powder per 5 gallons of water. Mix until dissolved. Administer at the indicated rates in the total water consumed over a full 24-hour period. Administer 7 to 14 days. |
| Control of Chronic Respiratory Disease (CRD) and air-sac infections caused by Mycoplasma gallisepticum and Escherichia coli susceptible to chlortetracycline. | 400-800 mg/gal (2-4 packets/512 gallons). This is equivalent to ½ - 1 oz of powder per 5 gallons of water. Mix until dissolved. Administer at the indicated rates in the total water consumed over a full 24-hour period. Administer 7 to 14 days. |
| Control of mortality due to fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline. | 1000 mg/gal (5 packets/512 gallons). This is equivalent to ¼ oz of powder per 1 gallon of water. Mix until dissolved. Administer at the indicated rates in the total water consumed over a full 24-hour period. Administer 7 to 14 days. |
| Growing Turkeys | Dose |
|---|---|
| Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline. | 400 mg/gal (2 packets/512 gallons). This is equivalent to ½ oz of powder per 5 gallons of water. Mix until dissolved. Administer at this rate in the total water consumed over a full 24-hour period. Administer 7 to 14 days. |
| Control of complicating bacterial organisms associated with Bluecomb (transmissible enteritis or coronaviral enteritis) susceptible to chlortetracycline. | 25 mg/lb body weight/day (1 packet for every 4,096 lbs of turkeys). ⅛ oz treats a 20 lb turkey for one day. Mix until dissolved. Administer in the total water consumed over a full 24 hour period. Administer 7 to 14 days. |
Medicate chickens and turkeys continuously at the first clinical signs of disease and continue for 7 to 14 consecutive days. The dosage ranges permitted provide for different levels based on the severity of the infection. If improvement is not noted in 24-48 hours, consult a veterinarian or a diagnostic laboratory to determine diagnoses and for advice regarding the optimal level of the drug where ranges are permitted.
| Swine | Dose – 10 mg/pound body weight daily |
|---|---|
| Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and Salmonella spp. and bacterial pneumonia associated with Pasturella spp., Actinobacillus pleuropneumoniae, and Klebsiella spp. susceptible to chlortetracycline. | (5 packets/512 gallons will treat 512 100-lb pigs per day). ¼ oz of powder will treat a 100 lb pig for one day. Mix until dissolved. Administer at this rate in the total water consumed over a full 24-hour period. Administer for 3 to 5 days. |
| Calves, Beef Cattle and Non-Lactating Dairy Cattle | Dose – 10 mg/pound body weight daily |
|---|---|
| Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and Salmonella spp. and bacterial pneumonia associated with Pasturella spp., Histophilus spp., and Klebsiella spp. susceptible to chlortetracycline. | Use ½ oz. of powder for each 200 lbs of calf weight, per day. Mix until dissolved. Administer at this rate in the total water consumed over a full, 24-hour period, or as a drench in divided doses. Administer 3 to 5 days. |
Other
Water Medicators: Dissolve the contents of one 25.6 oz packet in 100 oz of fresh water to prepare a stock solution, that when metered at the rate of 1 oz per gallon of drinking water, will deliver 1000 mg of chlortetracycline HCl per gallon. At this rate, a gallon of drinking water will treat a 100 lb pig or a 100 lb calf at the rate of 10 mg per lb of body weight for one day.
For technical assistance or to obtain a copy of the Safety Data Sheet, contact Pharmgate Animal Health LLC at 1-800-380-6099 or www.pharmgate.com. To report suspected adverse drug events, contact Pharmgate Animal Health LLC at 1-833-531-0114. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae
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Principal Display Panel - 725.7 G Packet Label
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Pennchlor 64®
(chlortetracycline HCl)
Soluble Powder Concentrate
CAUTION: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
Antibiotic
For Animal Use in Drinking Water
Chlortetracycline hydrochloride, 64 g per pound
This 25.6 oz packet contains 102.4 g
chlortetracycline HCl (64 g/lb) and will
make the resulting concentrations:
| Gallons | Chlortetracycline HCl per Gallon |
|---|---|
| 1024 | 100 mg |
| 512 | 200 mg |
| 256 | 400 mg |
| 102.4 | 1000 mg |
Net Contents: 25.6 oz (725.7 g)
Approved by FDA under ANADA #200-295
Not for Use in Humans.
Store at controlled room temperature 15°C to 30°C
(59°F to 86°F)
#F64-1 Rev. 6/22
Pharmgate
ANIMAL HEALTH
Marketed by:
Pharmgate Animal Health, LLC
14040 Industrial Road
Omaha, Nebraska 68144
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.