Animal NDC 54771-1439-1 Lincomix 20
Lincomycin Hydrochloride

Animal Product Information

Field Name Field Value
Animal NDC Code 54771-1439-1
Proprietary Name Lincomix 20 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 Zoetis Inc.
Product Type Vfd Type A Medicated Article Animal Drug
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 20 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



Description



LINCOMIX® 20

(lincomycin)
Type A Medicated Article
20 grams/lb

For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin in broilers.

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

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

Each pound contains:

                Active Drug Ingredient

                   Lincomycin ………………………………….20 grams

                      (as lincomycin hydrochloride agricultural grade)

                Inactive ingredients

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


IMPORTANT:

Must be thoroughly mixed in feeds before use.

Store open bag in dry place to prevent caking.

Store at room temperature.

 

Approved by FDA under NADA # 097-505


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.


Broilers



BROILERS

For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin in broilers.

 

DIRECTIONS FOR USE

For the control of necrotic enteritis:

LINCOMIX 20, 20 grams/lb, should be mixed into the complete feed supplied to broiler chickens so that the final feed contains 2 grams of lincomycin per ton of feed.

MIXING DIRECTIONS

Type C Medicated Feeds


Intermediate Premix

Amount of LINCOMIX 20 per 1000 lb

(454 kg) of Feed Ingredients

 

 

Complete Feed

Amount of Intermediate Premix to Provide 2 Grams

of lincomycin per ton of Type C Medicated Feed

lincomycin per ton of feed

2 grams

 

50 lbs

10 lbs

5 lbs

 

2 lb

10 lbs

20 lb

WARNING: When using LINCOMIX 20 in approved combinations with other drugs, follow the required withdrawal times for those drugs. No drug withdrawal period is required before slaughter of birds fed LINCOMIX 20 at the approved concentration (2 grams lincomycin per ton of feed).

CAUTION: Not for use in layers, breeders, or turkeys. (For additional Cautions, see below.)


Swine



SWINE

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

DIRECTIONS FOR USE

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

Feed 100 grams of lincomycin per ton of complete feed as the sole ration for three 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:

Feed 100 grams of lincomycin per ton of complete feed as the sole rations for three weeks, or until signs of disease (watery, mucoid or bloody stools) disappear, followed by 40 grams of lincomycin per ton.

For the control of swine dysentery and porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis: Feed 40 grams of lincomycin per ton of complete feed as the sole ration. For use in animals or on premises with a history of swine dysentery, but where symptoms have not yet occurred.

For reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniaeFeed 100-200 grams of lincomycin per ton of complete feed as the sole ration for 21 days.

MIXING DIRECTIONS

Type C Medicated Feeds

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

To make complete feed containing 100 grams of lincomycin, add 5 lbs of LINCOMIX 20 per ton.

For control of swine dysentery and porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis:

To make complete feed containing 40 grams of lincomycin, add 2 lbs of LINCOMIX 20 per ton.

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

To make complete feed containing 100-200 grams of lincomycin, add 5-10 lbs of LINCOMIX 20 per ton.

Additional mixing directions to make complete feed containing 40, 100 or 200 grams of lincomycin per ton are provided below.

MIXING DIRECTIONS

Intermediate Premix

Amount of LINCOMIX 20 per 1000 lb

(454 kg) of Feed Ingredients

Complete Feed

Amount of Intermediate Premix to Provide Desired Grams of lincomycin per ton of Type C Medicated Feed

125 lbs

100 lbs

50 lbs

lincomycin per ton of feed
40 grams    100 grams     200 grams

16 lbs         40 lbs           80 lbs

20 lbs         50 lbs          100 lbs

40 lbs       100 lbs          200 lbs

WARNING: When using LINCOMIX 20 in approved combinations with other drugs, follow the required withdrawal times for those drugs. No drug withdrawal period is required before slaughter of swine fed LINCOMIX 20 at approved concentrations (40, 100 or 100-200 grams lincomycin per ton of feed).

NOT FOR HUMAN USE

CAUTION: 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.


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