Animal NDC 51429-054-05 Pennitracin Md 50g
Bacitracin Methylenedisalicylate
Animal Product Information
Field Name | Field Value |
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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 |
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Active Ingredient(s) |
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Inactive Ingredient(s) |
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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 Time | Observe 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. | |||
Species | Grams of bacitracin per ton | Indications For Use | Feeding Directions |
Broiler and replacement chickens, growing turkeys, growing pheasants | 4-50 | For increased rate of weight gain and improved feed efficiency. | Feed as the sole ration throughout the feeding period. |
Broiler and replacement chickens | 50 | For 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 Quail | 5-20 | For 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/day | For reduction in the number of liver condemnations due to abscesses. | Feed as the sole ration throughout the feeding period. |
250 mg/head/day | For 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.