Animal NDC 51429-054-05 Pennitracin Md 50g
Bacitracin Methylenedisalicylate

Animal Product Information

Field Name Field Value
Animal NDC Code 51429-054-05
Proprietary Name Pennitracin Md 50g 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 Bacitracin Methylenedisalicylate 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
    See mixing directions, claims, cautions and warnings on back panel.Restricted Drug (California) - Use Only as Directed.Net wt. 50 LB (22.68 Kg)Pennitracin MD 50 G®(Bacitracin Type A medicated article)Active Drug Ingredients: Each pound contains feed grade bacitracin methylenedisalicylate equivalent to 50 grams bacitracinInactive Ingredients: Calcium Carbonate, Mineral OilCAUTION: For Use in Dry Feeds only. Not for use in liquid medicated feeds.Directions For UseApproved concentrations of bacitracin in Type C medicated feeds.SpeciesGrams of bacitracin per tonIndications For UseFeeding DirectionsBroiler and replacement chickens, growing turkeys, growing pheasants4-50For increased rate of weight gain and improved feed efficiency.Feed as the sole ration throughout the feeding period.Broiler and replacement chickens50For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens.Feed as the sole ration for 28 to 35 days, starting from the time chicks are placed for brooding.Growing Quail5-20For increased rate of weight gain and improved feed efficiency in quail not over 5 weeks of age.Feed as the sole ration through 5 weeks of age.Beef steers and heifers fed in confinement for slaughter 70 mg/head/dayFor reduction in the number of liver condemnations due to abscesses.Feed as the sole ration throughout the feeding period.250 mg/head/dayFor reduction in the number of liver condemnations due to abscesses.Feed as the sole ration for 5 days then discontinue for subsequent 25 days, repeat the pattern during the feeding period. .Mixing DirectionsPrepare an intermediate preblend containing 5 grams of bacitracin per pound by mixing 1.0 lb of Pennitracin MD 50G with 9.0 lbs of unmedicated feed ingredient(s), then add 0.8 to 10 lbs of the intermediate preblend per ton of the finished feed to obtain the appropriate g/ton concentration of the Type C medicated feed.Prepare Type B medicated feeds for chickens, turkeys, pheasants, or beef cattle containing 51 – 50,000 grams of bacitracin per ton by mixing 1.02 – 1,000 lbs of Pennitracin MD 50G with 1,998.98 – 1,000 lbs of unmedicated feed.CAUTION: For Use in Dry Feeds only. Not for use in liquid medicated feeds.WARNINGSWithdrawal Periods:No withdrawal period is required when used according to labeling.User Safety Warnings:Not for use in humans. Keep out of reach of children.Store at or below 25°C (77°F)Lot Number and Expiration Date: Both the Lot number and expiry date is provided on the front panel of the bag.QUESTIONS/COMMENTS? Contact Pharmgate Animal Health LLC at 1-800-380-6099 or www.pharmgate.com. To report side effects, contact Pharmgate Animal Health LLC at 1-833-531-0114. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.Approved by FDA under NADA # 141-137Pennitracin MD 50G® is a registered trademark of Pharmgate Inc.
Active Ingredient(s)
  • Bacitracin Methylenedisalicylate
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 NADA141137 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.

Pennitracin Md 50g 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



For further manufacturing only.

Marketed by:
PHARMGATE ANIMAL HEALTH LLC

14040 Industrial Road
Omaha, NE 68144

Take TimeObserve Directions

Veterinary Indications



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

Restricted Drug (California) - Use Only as Directed.

Net wt. 50 LB (22.68 Kg)

Pennitracin MD 50 G®

(Bacitracin Type A medicated article)

Active Drug Ingredients: Each pound contains feed grade bacitracin methylenedisalicylate equivalent to 50 grams bacitracin
Inactive Ingredients: Calcium Carbonate, Mineral Oil
CAUTION: For Use in Dry Feeds only. Not for use in liquid medicated feeds.
Directions For Use
Approved concentrations of bacitracin in Type C medicated feeds.
SpeciesGrams of bacitracin per tonIndications For UseFeeding Directions
Broiler and replacement chickens, growing turkeys, growing pheasants4-50For increased rate of weight gain and improved feed efficiency.Feed as the sole ration throughout the feeding period.
Broiler and replacement chickens50For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens.Feed as the sole ration for 28 to 35 days, starting from the time chicks are placed for brooding.
Growing Quail5-20For increased rate of weight gain and improved feed efficiency in quail not over 5 weeks of age.Feed as the sole ration through 5 weeks of age.
Beef steers and heifers fed in confinement for slaughter 70 mg/head/dayFor reduction in the number of liver condemnations due to abscesses.Feed as the sole ration throughout the feeding period.
250 mg/head/dayFor reduction in the number of liver condemnations due to abscesses.Feed as the sole ration for 5 days then discontinue for subsequent 25 days, repeat the pattern during the feeding period.
.Mixing Directions
Prepare an intermediate preblend containing 5 grams of bacitracin per pound by mixing 1.0 lb of Pennitracin MD 50G with 9.0 lbs of unmedicated feed ingredient(s), then add 0.8 to 10 lbs of the intermediate preblend per ton of the finished feed to obtain the appropriate g/ton concentration of the Type C medicated feed.
Prepare Type B medicated feeds for chickens, turkeys, pheasants, or beef cattle containing 51 – 50,000 grams of bacitracin per ton by mixing 1.02 – 1,000 lbs of Pennitracin MD 50G with 1,998.98 – 1,000 lbs of unmedicated feed.
CAUTION: For Use in Dry Feeds only. Not for use in liquid medicated feeds.
WARNINGS
Withdrawal Periods:
No withdrawal period is required when used according to labeling.
User Safety Warnings:
Not for use in humans. Keep out of reach of children.
Store at or below 25°C (77°F)
Lot Number and Expiration Date: Both the Lot number and expiry date is provided on the front panel of the bag.
QUESTIONS/COMMENTS? Contact Pharmgate Animal Health LLC at 1-800-380-6099 or www.pharmgate.com. To report side effects, contact Pharmgate Animal Health LLC at 1-833-531-0114. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.
Approved by FDA under NADA # 141-137
Pennitracin MD 50G® is a registered trademark of Pharmgate Inc.

Principal Display Panel - 22.68 Kg Bag



Pennitracin MD 50G®

(Bacitracin Type A medicated article)

For further manufacturing only.

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

Restricted Drug (California) - Use Only as Directed.

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.