Animal NDC 66104-8851-0 Neo-terramycin 100/100
Neomycin-oxytetracycline
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 66104-8851-0 |
| Proprietary Name | Neo-terramycin 100/100 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 | Neomycin-oxytetracycline 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 | Phibro Animal Health |
| Product Type | Vfd Type A Medicated Article 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 | NADA094975 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. |
Neo-terramycin 100/100 Images
Neo-terramycin 100/100 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
(Antibiotic)
NEO-TERRAMYCIN is a registered trademark of Pfizer, Inc
licensed to Phibro Animal Health Corporation for Neomycin-Oxytetracycline
PHIBRO and PHIBRO logo design are trademarks owned by
Phibro Animal Health Corporation or its affiliates.
Phibro Animal Health Corporation, Teaneck, NJ 07666
SEE BACK PANEL FOR COMPLETE MIXING DIRECTIONS
USE DIRECTIONS AND WARNINGS
Net Weight 50 lb (22.7 kg)
Approved by FDA under NADA # 094-975
8851000
101-9069-07
Active Drug Ingredients:
Oxytetracycline (from oxytetracycline dihydrate)
equivalent to oxytetracycline hydrochloride . . . . . . . . . . . . . . . . . . . . . . . . . . 100 g/lb
Neomycin Sulfate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 g/lb
Caution:
CAUTION: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.
CAUTION: For use in manufacturing medicated animal feeds only.
CAUTION: Certain components of animal feeds, including medicated premixes, possess properties that may be a potential health hazard or a source of personal discomfort to certain individuals who are exposed to them. Human exposure should, therefore, be minimized by observing the general industry standards for occupational health and safety.
Precautions such as the following should be considered: dust masks or respirators and protective clothing should be worn; dust-arresting equipment and adequate ventilation should be utilized; personal hygiene should be observed; wash before eating or leaving a work site; be alert for signs of allergic reactions—seek prompt medical treatment if such reactions are suspected.
Store In A Dry, Cool Place
STORE AT OR BELOW 25°C (77°F), EXCURSIONS PERMITTED UP TO 40°C (104°F)
Mixing And Use Directions
Thoroughly mix the amount of this Type A Medicated Article according to the directions below withat least an equal amount by weight of feed ingredients prior to blending into a complete feed.
Indications for Use | Oxytetracycline and Neomycin Amount | lb. of Neo-Terramycin 100/100 per ton |
CHICKENS | ||
Control of infectious synovitis caused by Mycoplasma synoviae; control of fowl cholera caused by Pasteurella multocida susceptible to oxytetracycline | 100-200 g/ton Feed continuously for 7-14 days | 1-2 |
Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and E. coli susceptible to oxytetracycline | 400 g/ton Feed continuously for 7-14 days | 4 |
Reduction of mortality due to air sacculitis (air sac infection) caused by E. coli susceptible to oxytetracycline | 500 g/ton Feed continuously for 5 days | 5 |
WARNING: At 500 g/ton level, withdraw 24 hours before slaughter. Low calcium feeds at 500 g/ton, withdraw 3 days before slaughter. Zero-day withdrawal period for lower use levels. In low calcium feeds withdraw 3 days before slaughter. Do not administer to chickens producing eggs for human consumption. | ||
TURKEYS | ||
Control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline | 100 g/ton Feed continuously for 7-14 days | 1 |
Control of infectious synovitis caused by Mycoplasma synoviae susceptible to oxytetracycline | 200 g/ton Feed continuously for 7-14 days | 2 |
Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to oxytetracycline | 25 mg/lb of body weight daily Feed continuously for 7-14 days | 8.351 |
WARNING: At 200 g/ton use level or higher, withdraw 5 days before slaughter. Zero-day withdrawal period for lower use levels. Do not administer to turkeys producing eggs for human consumption. | ||
SWINE | ||
Treatment of bacterial enteritis caused by E. coli and Salmonella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin | 10 mg/lb of body weight daily Feed continuously for 7-14 days | 52 |
For breeding swine for control and treatment of Leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline | 10 mg/lb of body weight daily Feed continuously for not more than 14 days | 52 |
WARNING: 5-day withdrawal before slaughter at 10 mg/lb dosage. | ||
CALVES, BEEF CATTLE, AND NONLACTATING DAIRY CATTLE | ||
For growing cattle (over 400 lb) for reduction of liver condemnation due to liver abscesses | 75 mg/head/day Feed continuously | 0.753 |
Prevention and treatment of the early stages of shipping fever complex | 0.5-2.0 g/head/day Feed 3-5 days before and after arrival in feedlots | 5-203 |
Treatment of bacterial enteritis caused by E. coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin | 10 mg/lb of body weight daily Feed continuously for 7-14 days Treatment should continue 24 to 48 hours beyond remission of disease symptoms. | 504 |
For calves (up to 250 lb) for treatment of bacterial enteritis caused by E. coli susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin | 10 mg/lb of body weight daily Feed continuously for 7-14 days Treatment should continue 24 to 48 hours beyond remission of disease symptoms. | 105 |
WARNING: A withdrawal period has not been established in preruminating calves; do not use in calves to be processed for veal. At the 0.5-2.0 g/head/day and 10 mg/lb levels: A milk discard time has not been established for use in lactating dairy cattle; do not use in female dairy cattle 20 months of age or older. At the 10 mg/lb level, withdraw 5 days before slaughter. Use of more than one product containing neomycin or failure to follow withdrawal times may result in illegal drug residues. | ||
SHEEP | ||
Treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin | 10 mg/lb of body weight daily Feed continuously for 7-14 days Treatment should continue 24 to 48 hours beyond remission of disease symptoms. | 126 |
WARNING: 5-day withdrawal before slaughter at 10 mg/lb dosage. | ||
1If bird weighs 10 lb, consuming 0.6 lb of complete feed per day 2If pig weighs 100 lb, consuming 4 lb of complete feed per day 3Include in feed supplement based on consumption of 2 lb of supplement per head per day 4If animal weighs 500 lb, consuming 2 lb of supplement per head per day 5If calf weighs 100 lb, consuming 2 lb of complete starter feed per day 6If lamb weighs 60 lb, consuming 1 lb of supplement per head per day | ||
Indications & Usage
FOR USE IN ANIMAL FEEDS ONLY
NOT FOR HUMAN USE
RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.
