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Animal NDC 66104-1494-2 Lincomix 50

Lincomycin Hydrochloride

Animal Product Information

Field Name Field Value
Animal NDC Code 66104-1494-2
Proprietary Name Lincomix 50 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 Lincomycin 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 Phibro Animal Health
Product Type Vfd Type A Medicated Article Animal Drug
Usage Information
    INDICATIONS FOR USE For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin in broiler chickens. Not for use in laying hens, breeder chickens, or turkeys.For the treatment and control of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis in swine.For reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae in swine.Each pound contains:Active Drug IngredientLincomycin.................................50 grams(as lincomycin hydrochloride agricultural grade)Inactive IngredientsSoybean hulls, #20 grind; light liquid paraffin, Ph.Eur.
Active Ingredient(s)
  • Lincomycin Hydrochloride
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 NADA097505 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.

Lincomix 50 Images

Lincomix 50 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



Indications For Use



INDICATIONS FOR USE
For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin in broiler chickens. Not for use in laying hens, breeder chickens, or turkeys.

For the treatment and control of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis in swine.

For reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae in swine.

Each pound contains:

Active Drug Ingredient

Lincomycin.................................50 grams

(as lincomycin hydrochloride agricultural grade)

Inactive Ingredients

Soybean hulls, #20 grind; light liquid paraffin, Ph.Eur.


Storage, Handling And Disposal



Store opened bag in dry place to prevent caking. Store at room temperature.

Approved by FDA under NADA # 097-505

LOT:

EXP:

MFG:

 

NET WEIGHT 50 lb (22.7 kg)


Broilers



BROILER CHICKENS

INDICATIONS FOR USE

For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin in broiler chickens. Not for use in laying hens, breeding chickens, or turkeys.

MIXING DIRECTIONS (Type C medicated feeds)
Thoroughly mix LINCOMIX 50 Type A medicated article with non-medicated broiler chicken feed to obtain 2 g/ton lincomycin in the complete Type C medicated feed. Prepare an intermediate pre-blend of the Type A medicated article prior to mixing in a complete Type C medicated feed. Thoroughly mix 0.04 lb (18 grams) of the Type A medicated article in a convenient quantity of feed ingredients, then thoroughly mix this pre-blend with the rest of the feed ingredients to ensure complete and uniform distribution of the Type A medicated article.

FEEDING DIRECTIONS
Feed a Type C medicated feed containing 2 g/ton lincomycin as the sole ration to broiler chickens.



Swine



SWINE
INDICATIONS FOR USE
For the treatment and control of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis in swine. For reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae in swine.


MIXING DIRECTIONS (Type B medicated feeds)
Thoroughly mix LINCOMIX 50 Type A medicated article with non-medicated swine feed according to the table below to obtain the proper concentration in the Type B medicated feed (201 to 40,000 grams lincomycin per ton).


The following table gives examples of how some Type B medicated feed concentrations can be prepared:

Pounds of LINCOMIX 50 Type A Medicated Article to

Add per Ton to Make a Type B Medicated Feed 

Resulting Lincomycin Concentration in

Type B Medicated Feed (grams/ton) 

 4.02201 
 201,000 
 1005,000 
 20010,000 
 40020,000 
 80040,000 

MIXING DIRECTIONS (Type C medicated feeds)
Thoroughly mix LINCOMIX 50 Type A medicated article with non-medicated swine feed according to the table below to obtain the proper concentration of lincomycin in the complete Type C medicated feed. Prepare an intermediate pre-blend of the Type A medicated article prior to mixing in a complete Type C medicated feed. Thoroughly mix the required amount of Type A medicated article in a convenient quantity of feed ingredients, then thoroughly mix this pre-blend with the rest of the feed ingredients to ensure complete and uniform distribution of the Type A medicated article.

The following table gives examples of how some Type C medicated feed concentrations can be prepared:

Pounds of LINCOMIX 50 Type A Medicated Article to

Add per Ton to Make a Type C Medicated Feed 

Resulting Lincomycin Concentration in

Type C Medicated Feed (grams/ton) 

 0.840 
 2100 
 3150 
 4200 

FEEDING DIRECTIONS
For the treatment of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis in swine.

Feed a Type C medicated feed containing 100 g/ton lincomycin as the sole ration to swine for 3 weeks or until signs of disease (watery, mucoid, or bloody stools) disappear.

For the treatment and control of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis in swine.

Feed a Type C medicated feed containing 100 g/ton lincomycin as the sole ration to swine for 3 weeks or until signs of disease (water, mucoid, or bloody stools) disappear, followed by a Type C medicated feed containing 40 g/ton lincomycin as the sole ration.

For the control of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis in swine.

For use in swine or on premises with a history of swine dysentery but where symptoms have not yet occurred. Feed a Type C medicated feed containing 40 g/ton lincomycin as the sole ration to swine.

For reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae in swine.

Feed a Type C medicated feed containing 100 to 200 g/ton lincomycin as the sole ration to swine for 21 days.



Withdrawal Periods



No withdrawal period is required when used according to labeling.


User Safety Warning



Not for use in humans. Keep out of reach of children.


Animal Safety Warnings



Occasionally, swine fed lincomycin may within the first two days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-correcting within five to eight days without discontinuing the lincomycin treatment. The effects of lincomycin on swine reproductive performance, pregnancy, and lactation have not been determined.

Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.


Principal Display Panel



Lincomix 50 Label

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