Animal NDC 23243-6752-4 Lincomycin Hydrochloride Soluble Powder

Lincomycin Hydrochloride

Animal Product Information

Field Name Field Value
Animal NDC Code 23243-6752-4
Proprietary Name Lincomycin Hydrochloride Soluble Powder 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 Huvepharma, Inc.
Product Type Prescription Animal Drug
Usage Information
    For Oral Use in Swine and Broiler Chickens OnlyNot for use in layer or breeder chickensKeep Out of Reach of ChildrenINDICATIONS AND USAGE:Swine: Lincomycin Hydrochloride Soluble Powder is indicated for the treatment of swine dysentery (bloody scours).Broiler Chickens: Lincomycin Hydrochloride Soluble Powder is indicated for the control of necrotic enteritis causedby Clostridium perfringens susceptible to lincomycin.
Active Ingredient(s)
  • Lincomycin Hydrochloride
Marketing Category ANADA - ABBREVIATED 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 ANADA200189 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.

Lincomycin Hydrochloride Soluble Powder 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



80 Gram Front Panel



Lincomycin Hydrochloride Soluble Powder
Antibacterial


General Precautions



CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.


Storage And Handling



This packet contains as an active ingredient:
Lincomycin HCl, equivalent to 32 g lincomycin
Store between 20˚C - 25˚C (68˚F - 77˚F) with excursions permitted
between 15˚C - 40˚C (59˚F - 104˚F).
See back for instructions.

Net Weight
80 grams
(2.82 oz)

This packet contains as an active ingredient:
Lincomycin HCl, equivalent to 64 g lincomycin

Store between 20˚C - 25˚C (68˚F - 77˚F) with excursions permitted
between 15˚C - 40˚C (59˚F - 104˚F). See back for instructions.

Net Weight
160 grams
(5.64 oz)

This packet contains as an active ingredient:
Lincomycin HCl, equivalent to 192 g lincomycin
Store between 20˚C - 25˚C (68˚F - 77˚F) with excursions permitted between 15˚C - 40˚C (59˚F - 104˚F).
See back for instructions.

Net Weight
480 grams
(16.92 oz)


80 G Front Panel



For Oral Use in Swine and Broiler Chickens Only
Not for use in layer and breeder chickens
Keep Out of Reach of Children

INDICATIONS AND USAGE:
Swine: Lincomycin Hydrochloride Soluble Powder is indicated for the treatment of swine dysentery (bloody scours).
Broiler Chickens: Lincomycin Hydrochloride Soluble Powder is indicated for the control of necrotic enteritis caused
by Clostridium perfringens susceptible to lincomycin.


Adverse Reactions



To report suspected adverse drug events, for technical assistance or
to obtain a copy of the Safety Data Sheet (SDS), contact Huvepharma,
Inc. at 1-877-994-4883 or www.huvepharma.us. For additional
information about adverse drug experience reporting for animal drugs,
contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

To report suspected adverse drug events, for technical assistance or
to obtain a copy of the Safety Data Sheet (SDS), contact Huvepharma,
Inc. at 1-877-994-4883 or www.huvepharma.us. For additional
information about adverse drug experience reporting for animal drugs,
contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

To report suspected adverse drug events, for technical assistance or
to obtain a copy of the Safety Data Sheet (SDS), contact Huvepharma,
Inc. at 1-877-994-4883 or www.huvepharma.us. For additional
information about adverse drug experience reporting for animal drugs,
contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.


Residue Warning



RESIDUE WARNINGS:
No drug withdrawal period is required before slaughter of swine receiving Lincomycin Hydrochloride
Soluble Powder at the approved level of 250 mg per gallon of drinking water, nor before slaughter
of birds receiving Lincomycin Hydrochloride Soluble Powder at the approved level of 64 mg per
gallon of drinking water.

RESIDUE WARNINGS:
No drug withdrawal period is required before slaughter of swine receiving Lincomycin Hydrochloride
Soluble Powder at the approved level of 250 mg per gallon of drinking water, nor before slaughter
of birds receiving Lincomycin Hydrochloride Soluble Powder at the approved level of 64 mg per
gallon of drinking water.

RESIDUE WARNINGS:
No drug withdrawal period is required before slaughter of
swine receiving Lincomycin Hydrochloride Soluble Powder at
the approved level of 250 mg per gallon of drinking water, nor
before slaughter of birds receiving Lincomycin Hydrochloride
Soluble Powder at the approved level of 64 mg per gallon of
drinking water.


Other



Huvepharma®
Manufactured for:
Huvepharma, Inc.
525 Westpark Drive, Suite 230
Peachtree City, GA 30269

Restricted Drug (California) - Use only as directed.
Not for Human Use.
Approved by FDA under ANADA # 200-189
KCP-S00054
P08-3902BF (Rev. 03-2022)

Huvepharma®
Manufactured for:
Huvepharma, Inc.
525 Westpark Drive, Suite 230
Peachtree City, GA 30269

Restricted Drug (California) - Use only as directed.
Not for Human Use.
Approved by FDA under ANADA # 200-189
KCP-S00093
P08-3903BF (Rev. 03-2022)

Huvepharma®
Manufactured for:
Huvepharma, Inc.
525 Westpark Drive, Suite 230
Peachtree City, GA 30269

Restricted Drug (California) - Use only as directed.
Not for Human Use.
Approved by FDA under ANADA # 200-189
KCP-S00097
KLA-N00004 (Rev. 12-2022)


Dosage & Administration



BROILER CHICKENS: Directions for use
DOSAGE AND ADMINISTRATION
Dosage: Administer at a dose rate of 64 mg of lincomycin per gallon of drinking water.
Treatment Period: Start medication as soon as the diagnosis of necrotic enteritis is determined. The drug
should be administered for 7 consecutive days. Administration: This packet will medicate 500 gallons of
drinking water providing 64 mg/gallon.
Note: After water medication is discontinued, a control program for necrotic enteritis may be followed by
feeding lincomycin premix at 2 grams lincomycin per ton of complete feed.

SWINE: Directions for use
DOSAGE AND ADMINISTRATION
Dosage: Administer at a dose rate of 250 mg of lincomycin per gallon of drinking water. In clinical
studies, this dose rate provided an average of 3.8 mg of lincomycin per lb of body weight per day.
Treatment Period: The drug should be administered for a minimum of 5 consecutive days beyond the
disappearance of symptoms (bloody stools) up to a maximum of 10 consecutive days. If water treatment
is discontinued prior to this time, a lincomycin treatment program may be continued with lincomycin
premix at 100 g lincomycin per ton of complete feed as the sole ration according to label directions.
Administration: This packet will medicate 128 gallons of drinking water providing 250 mg/gallon. A dose
of 3.8 mg lincomycin per lb of body weight may be maintained by medicating the drinking water at a
concentration of 250 mg per gallon of drinking water when pigs are consuming 1.5 gallons per 100 lbs of
body weight per day. Under these circumstances the concentration of lincomycin required in medicated
water may be adjusted to compensate for variations in age and weight of animals, the nature and
severity of disease symptoms, environmental temperature and humidity, each of which affects water
consumption. For use in automatic water proportioners, prepare the stock solution by dissolving 1 packet
in 1 gallon of water: then adjust the proportioner to deliver 1 oz of stock solution per gallon of drinking
water.
Note: After a treatment program is discontinued, a control program for swine dysentery may be followed
by feeding lincomycin premix at 40 grams lincomycin per ton of complete feed as the sole ration.

BROILER CHICKENS: Directions for use
DOSAGE AND ADMINISTRATION
Dosage: Administer at a dose rate of 64 mg of lincomycin per gallon of drinking water.
Treatment Period: Start medication as soon as the diagnosis of necrotic enteritis is determined. The drug should be administered for 7
consecutive days.
Administration: This packet will medicate 1000 gallons of drinking water providing 64 mg/gallon.
Note: After water medication is discontinued, a control program for necrotic enteritis may be followed by feeding lincomycin premix at 2
grams lincomycin per ton of complete feed.

SWINE: Directions for use
DOSAGE AND ADMINISTRATION
Dosage: Administer at a dose rate of 250 mg of lincomycin per gallon of drinking water. In clinical studies, this dose rate provided an
average of 3.8 mg of lincomycin per lb of body weight per day.
Treatment Period: The drug should be administered for a minimum of 5 consecutive days beyond the disappearance of symptoms
(bloody stools) up to a maximum of 10 consecutive days. If water treatment is discontinued prior to this time, a lincomycin
treatment program may be continued with lincomycin premix at 100 g lincomycin per ton of complete feed as the sole ration
according to label directions.
Administration: This packet will medicate 256 gallons of drinking water providing 250 mg/gallon. A dose of 3.8 mg lincomycin per lb
of body weight may be maintained by medicating the drinking water at a concentration of 250 mg per gallon of drinking water when
pigs are consuming 1.5 gallons per 100 lbs of body weight per day. Under these circumstances the concentration of lincomycin
required in medicated water may be adjusted to compensate for variations in age and weight of animals, the nature and severity of
disease symptoms, environmental temperature and humidity, each of which affects water consumption. For use in automatic water
proportioners, prepare the stock solution by dissolving 1 packet in 2 gallons of water: then adjust the proportioner to deliver 1 oz of
stock solution per gallon of drinking water.
Note: After a treatment program is discontinued, a control program for swine dysentery may be followed by feeding lincomycin
premix at 40 grams lincomycin per ton of complete feed as the sole ration.

BROILER CHICKENS: Directions for use
DOSAGE AND ADMINISTRATION
Dosage: Administer at a dose rate of 64 mg of lincomycin per gallon of drinking water.
Treatment Period: Start medication as soon as the diagnosis of necrotic enteritis is determined. The drug should be administered for 7
consecutive days.
Administration: This packet will medicate 3000 gallons of drinking water providing 64 mg/gallon.
Note: After water medication is discontinued, a control program for necrotic enteritis may be followed by feeding lincomycin premix at 2
grams lincomycin per ton of complete feed.

SWINE: Directions for use
DOSAGE AND ADMINISTRATION
Dosage: Administer at a dose rate of 250 mg of lincomycin per gallon of drinking water. In clinical studies, this dose rate provided an average of 3.8 mg of lincomycin per lb of body weight per day.
Treatment Period: The drug should be administered for a minimum of 5 consecutive days beyond the disappearance of symptoms (bloody stools) up to a maximum of 10 consecutive days. If water treatment is discontinued prior to this time, a lincomycin treatment program may be continued with lincomycin premix at 100 g lincomycin per ton of complete feed as the sole ration according to label directions.
Administration: This packet will medicate 768 gallons of drinking water providing 250 mg/gallon. A dose of 3.8 mg lincomycin per lb of body weight may be maintained by medicating the drinking water at a concentration of 250 mg per gallon of drinking water when pigs are consuming 1.5 gallons per 100 lbs of body weight per day. Under these circumstances the concentration of lincomycin required in medicated water may be adjusted to compensate for variations in age and weight of animals, the nature and severity of disease symptoms, environmental temperature and humidity, each of which affects water consumption. For use in automatic water proportioners, prepare the stock solution by dissolving 1 packet in 6 gallons of water: then adjust the proportioner to deliver 1 oz of stock solution per gallon of drinking water.
Note: After a treatment program is discontinued, a control program for swine dysentery may be followed by feeding lincomycin premix at 40 grams lincomycin per ton of complete feed as the sole ration.


Precautions



PRECAUTIONS:
Discard medicated drinking water if not used within 2 days. Fresh stock solution should be prepared
daily. Do not use the water treatment and the feed treatment simultaneously. Do not allow rabbits,
hamsters, guinea pigs, horses, or ruminants access to water containing lincomycin. Ingestion by these
species may result in severe gastrointestinal effects.
Swine: If clinical signs of bloody scours (watery, mucoid or bloody stools) have not improved during the
first 6 days of medication, discontinue treatment and redetermine the diagnosis. Occasionally, swine fed
lincomycin may within the first 2 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 5 to 8 days without discontinuing the lincomycin treatment.
The safety of lincomycin has not been demonstrated for pregnant swine or swine intended for breeding.
Chickens: Not for use in layer and breeder chickens.

PRECAUTIONS:
Discard medicated drinking water if not used within 2 days. Fresh stock solution should be prepared daily. Do not use the water
treatment and the feed treatment simultaneously. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to water
containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.
Swine: If clinical signs of bloody scours (watery, mucoid or bloody stools) have not improved during the first 6 days of medication,
discontinue treatment and redetermine the diagnosis. Occasionally, swine fed lincomycin may within the first 2 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 5 to 8 days without discontinuing the lincomycin treatment. The safety of
lincomycin has not been demonstrated for pregnant swine or swine intended for breeding.
Chickens: Not for use in layer and breeder chickens.

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

PRECAUTIONS:
Discard medicated drinking water if not used within 2 days. Fresh stock solution
should be prepared daily. Do not use the water treatment and the feed treatment
simultaneously. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants
access to water containing lincomycin. Ingestion by these species may result in
severe gastrointestinal effects.
Swine: If clinical signs of bloody scours (watery, mucoid or bloody stools) have
not improved during the first 6 days of medication, discontinue treatment and
redetermine the diagnosis. Occasionally, swine fed lincomycin may within the
first 2 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 5 to 8 days without
discontinuing the lincomycin treatment. The safety of lincomycin has not been
demonstrated for pregnant swine or swine intended for breeding.
Chickens: Not for use in layer and breeder chickens.


160 Gram Front Panel



Lincomycin Hydrochloride Soluble Powder
Antibacterial


Indications & Usage



For Oral Use in Swine and Broiler Chickens Only

Not for use in layer or breeder chickens

Keep Out of Reach of Children

INDICATIONS AND USAGE:

Swine: Lincomycin Hydrochloride Soluble Powder is indicated for the treatment of swine dysentery (bloody scours).

Broiler Chickens: Lincomycin Hydrochloride Soluble Powder is indicated for the control of necrotic enteritis caused
by Clostridium perfringens susceptible to lincomycin.


480 Gram Front Panel



Lincomycin Hydrochloride Soluble Powder
Antibacterial


Veterinary Indications



For Oral Use in Swine and Broiler Chickens Only
Not for use in layer and breeder chickens
Keep Out of Reach of Children

INDICATIONS AND USAGE:

Swine: Lincomycin Hydrochloride Soluble Powder is indicated 
for the treatment of swine dysentery (bloody scours).
Broiler Chickens: Lincomycin Hydrochloride Soluble Powder is 
indicated for the control of necrotic enteritis caused by Clostridium
perfringens susceptible to lincomycin.


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