Animal NDC 66104-7100-0 Terramycin 100

Oxytetracycline

Animal Product Information

Field Name Field Value
Animal NDC Code 66104-7100-0
Proprietary Name Terramycin 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 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
Active Ingredient(s)
  • Oxytetracycline Hydrochloride
Inactive Ingredient(s)
  • MINERAL OIL (T5L8T28FGP)
  • CALCIUM CARBONATE (H0G9379FGK)
  • RICE BRAN (R60QEP13IC)
  • MINERAL OIL (T5L8T28FGP)
  • CALCIUM CARBONATE (H0G9379FGK)
  • RICE BRAN (R60QEP13IC)
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 NADA095143 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.

Terramycin 100 Images

Terramycin 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



Active Drug Ingredient:



Oxytetracycline (from oxytetracycline dihydrate base) equivalent to

oxytetracycline hydrochloride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 At Or Below 25°C (77°F), Excursions Permitted Up To 40°C (104°F)



SEE BACK PANEL FOR COMPLETE MIXING DIRECTIONS,

USE DIRECTIONS, AND WARNINGS

Terramycin is a registered trademark of Pfizer, Inc.,

licensed to Phibro Animal Health Corporation, for Oxytetracycline

PHIBRO and PHIBRO logo design are trademarks owned by

Phibro Animal Health Corporation or its affiliates

Phibro Animal Health Corporation, Teaneck, NJ 07666

Net Weight 50 lb (22.7 kg)

Approved by FDA under NADA # 095-143

8844000

101-9008-10


For Use In Dry Feeds Only. Not For Use In Liquid Feed Supplements.



Mixing and Use Directions

Thoroughly mix the amount of this Type A medicated article according to the directions below with at least an equal amount by weight of feed formula ingredients prior to blending into a complete feed.

Indications for Use

Oxytetracycline Amount

lb of
Terramycin 100/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 Escherichia 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 Escherichia coli susceptible to oxytetracycline

500 g/ton

Feed continuously for 5 days

5

WARNING: At 500 g/ton level, withdraw 24 hours before slaughter. Zero-day withdrawal period for lower use levels. Do not use in low-calcium feed containing less than 0.55 dietary calcium. Use in such may result in violative residues. 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

8.31

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 Escherichia coli and Salmonella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline

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

CALVES, BEEF CATTLE, AND NONLACTATING DAIRY CATTLE

For growing cattle (over 400 lb) for the reduction of the incidence of liver abscesses

75 mg/head/day

Feed continuously

0.753

Prevention and treatment of the early stages of shipping fever complex (Feed 3-5 days before and after arrival in feedlots.)

0.5-2.0 g/head/day

5-203

Treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline

10 mg/lb of body weight daily

Feed continuously for 7-14 days

504

SHEEP

Treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline

10 mg/lb of body weight daily

Feed continuously for 7-14 days

125

WARNING: 5-day withdrawal before slaughter.

1If bird weighs 10 lb, consuming 0.6 lb of complete feed per day

2Pig consuming 4 lb of complete feed per 100 lb body weight 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 lamb weighs 60 lb, consuming 1 b of supplement per head per day

RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED

NOT FOR HUMAN USE


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