Animal NDC 23243-6759-3 Oxytet Soluble

Oxytetracycline Hydrochloride

Animal Product Information

Field Name Field Value
Animal NDC Code 23243-6759-3
Proprietary Name Oxytet Soluble 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 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
    Mix fresh solutions daily. Use as the sole source of drinking water.Do not mix this product directly with milk or milk replacers. Administer1 hour before or 2 hours after feeding milk or milk replacers. As ageneralization, 200 chickens will drink 1 gallon of water per day foreach week of age. Turkeys will consume twice that amount. Administer upto 5 days to swine and 7 to 14 days for chickens and turkeys. NOTE: Theconcentration of drug required in medicated water must be adequate tocompensate for variation in the age of the animal, feed consumption rate,and the environmental temperatures and humidity, each of which affects waterconsumption. Mix fresh solutions daily. Use as the sole source of drinking water.Do not mix this product directly with milk or milk replacers. Administer1 hour before or 2 hours after feeding milk or milk replacers. As ageneralization, 200 chickens will drink 1 gallon of water per day foreach week of age. Turkeys will consume twice that amount. Administerup to 5 days to swine and 7 to 14 days for chickens and turkeys.NOTE: The concentration of drug required in medicated water must beadequate to compensate for variation in the age of the animal, feedconsumption rate, and the environmental temperatures and humidity,each of which affects water consumption. Mix fresh solutions daily. Use as the sole source of drinking water.Do not mix this product directly with milk or milk replacers. Administer 1 hour beforeor 2 hours after feeding milk or milk replacers. As a generalization, 200 chickenswill drink 1 gallon of water per day for each week of age. Turkeys will consume twicethat amount. Administer up to 5 days to swine and 7 to 14 days for chickens and turkeys.NOTE: The concentration of drug required in medicated water must be adequate to compensatefor variation in the age of the animal, feed consumption rate, and the environmentaltemperatures and humidity, each of which affects water consumption.
Active Ingredient(s)
  • Oxytetracycline Hydrochloride
Inactive Ingredient(s)
  • ANHYDROUS CITRIC ACID (XF417D3PSL)
  • ANHYDROUS CITRIC ACID (XF417D3PSL)
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 NADA130435 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.

Oxytet Soluble 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



280 Gram Front Panel



Oxytet® Soluble

(oxytetracycline hydrochloride soluble powder)
Antibiotic

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

This packet contains 102.4 g of oxytetracycline hydrochloride and will make:

512 gallons (1936 liters) containing 200 mg oxytetracycline hydrochloride per gallon
128 gallons (484 liters) containing 800 mg oxytetracycline hydrochloride per gallon

                  This packet will treat 10,240 lbs of swine.
This packet will treat 4,096 lbs of turkey at 25 mg/lb body weight.

RECOMMENDED PACKET
STORAGE CONDITIONS:
Store between 20°C - 25°C
(68°F - 77°F) with excursions
permitted between 15°C - 40°C
(59°F - 104°F).
See back panel for instructions.
Net Weight: 9.87 oz (280 g)

For Use in Drinking Water Only 

Not For Use in Liquid Medicated Feeds

Not For Use in Humans 

Keep Out of Reach of Children

HAZARDOUS REMEDY

Restricted Drug (California) - Use
only as directed.

HUVEPHARMA®

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

HUVEPHARMA and Oxytet
are registered trademarks of
Huvepharma EOOD 

13925000 (Rev. 02-2021)
Approved by FDA under NADA #130-435


Use Directions:



Mix fresh solutions daily. Use as the sole source of drinking water.
Do not mix this product directly with milk or milk replacers. Administer
1 hour before or 2 hours after feeding milk or milk replacers. As a
generalization, 200 chickens will drink 1 gallon of water per day for
each week of age. Turkeys will consume twice that amount. Administer up
to 5 days to swine and 7 to 14 days for chickens and turkeys. NOTE: The
concentration of drug required in medicated water must be adequate to
compensate for variation in the age of the animal, feed consumption rate,
and the environmental temperatures and humidity, each of which affects water
consumption.

Mix fresh solutions daily. Use as the sole source of drinking water.
Do not mix this product directly with milk or milk replacers. Administer
1 hour before or 2 hours after feeding milk or milk replacers. As a
generalization, 200 chickens will drink 1 gallon of water per day for
each week of age. Turkeys will consume twice that amount. Administer
up to 5 days to swine and 7 to 14 days for chickens and turkeys.
NOTE: The concentration of drug required in medicated water must be
adequate to compensate for variation in the age of the animal, feed
consumption rate, and the environmental temperatures and humidity,
each of which affects water consumption.

Mix fresh solutions daily. Use as the sole source of drinking water.
Do not mix this product directly with milk or milk replacers. Administer 1 hour before
or 2 hours after feeding milk or milk replacers. As a generalization, 200 chickens
will drink 1 gallon of water per day for each week of age. Turkeys will consume twice
that amount. Administer up to 5 days to swine and 7 to 14 days for chickens and turkeys.
NOTE: The concentration of drug required in medicated water must be adequate to compensate
for variation in the age of the animal, feed consumption rate, and the environmental
temperatures and humidity, each of which affects water consumption.


Caution



Use as the sole source of oxytetracycline. Not to be used for more than 5 consecutive days in swine or 14
consecutive days in chickens and turkeys.


Warning -



Do not feed to birds producing eggs for human consumption.

Do not feed to birds producing eggs for human consumption.

Do not feed to birds producing eggs for human consumption.


Mixing Directions For Water Medication Chickens — Turkeys — Swine



Dosage and indications for use in water proportioners - Add the following amount to 1 gallon of stock solution when proportioner is set to meter at the rate of 1 oz per gallon.

 C

 H

 I 

 C

 K

 E

 N

 S

DiseaseTreatment LevelPack/Gallon Stock
Control of infectious synovitis caused by Mycoplasma synoviae, susceptible to oxytetracycline.    200 - 400 mg ¼ - ½ (70 - 140 g)
Control of chronic respiratory disease (CRD) and air sac infections caused by Mycoplasma gallisepticum
and Escherichia coli, susceptible to oxytetracycline.
   400 - 800 mg ½ - 1 (140 - 280 g)
Control of fowl cholera caused by Pasteurella multocida, susceptible to oxytetracycline.   400 - 800 mg½ - 1 (140 - 280 g)

 T

 U

 R

 K

 E

 Y

 S

Control of hexamitiasis caused by Hexamita meleagridis, susceptible to oxytetracycline.    200 - 400 mg ¼ - ½ (70 - 140 g)
Control of infectious synovitis caused by Mycoplasma synoviae, susceptible to oxytetracycline.        400 mg ½ (140 g)
GROWING TURKEYS — Control of complicating bacterial organisms associated with bluecomb
(transmissible enteritis, coronaviral enteritis), susceptible to oxytetracycline.

      25 mg/lb

    body weight

Varies with age &
water

consumption

 S

 W

 I

 N

 E

FOR THE CONTROL AND TREATMENT OF THE FOLLOWING DISEASES IN SWINE –
Bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis, susceptible to oxytetracycline. Bacterial pneumonia caused by Pasteurella multocida, susceptible to oxytetracycline.
FOR BREEDING SWINE: Leptospirosis (reducing the incidence of abortions and shedding of leptospira) caused by Leptospira pomona, susceptible to oxytetracycline. 
     10 mg/lb
   body weight
Varies with age &
water consumption 

Dosage and indications for use in water proportioners - Add 1 pack to the following amount of water to make a stock solution for use in a proportioner set to meter at the rate of one ounce per gallon.

 C
 H
 I 
 C
 K
 E
 N
 S
                                                               Disease Treatment Level Gallons Stock/Pack
 Control of infectious synovitis caused by Mycoplasma synoviae, susceptible to oxytetracycline. 200 - 400 mg          20 - 10
 Control of chronic respiratory disease (CRD) and air sac infections caused by Mycoplasma gallisepticum and Escherichia coli, susceptible to oxytetracycline. 400 - 800 mg          10 - 5
 Control of fowl cholera caused by Pasteurella multocida, susceptible to oxytetracycline. 400 - 800 mg          10 - 5
T
 U
 R
 K
 E
 Y
 S
 Control of hexamitiasis caused by Hexamita meleagridis, susceptible to oxytetracycline. 200 - 400 mg          20 - 10
 Control of infectious synovitis caused by Mycoplasma synoviae, susceptible to oxytetracycline. 400 mg             10
 GROWING TURKEYS — Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis), susceptible to oxytetracycline. 25 mg/lb
body weight

      Varies with age    & water consumption

 S
 W
 I
 N
 E
FOR THE CONTROL AND TREATMENT OF THE FOLLOWING DISEASES IN SWINE –
Bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis, susceptible to oxytetracycline.
Bacterial pneumonia caused by Pasteurella multocida, susceptible to oxytetracycline.
FOR BREEDING SWINE: Leptospirosis (reducing the incidence of abortions and shedding of leptospira) caused by Leptospira pomona, susceptible to oxytetracycline.
 10 mg/lb
body weight
     Varies with age &
   water consumption

Dosage and indications for use in water proportioners - Add 1 pack to the following amount of water to make a stock solution for use in a proportioner set to meter at the rate of one ounce per gallon.

 C
 H
 I
 C
 K
 E
 N
 S 
DiseaseTreatment Level Gallons Stock/Pack
Control of infectious synovitis caused by Mycoplasma synoviae, susceptible to oxytetracycline.200 - 400 mg    25.3 - 12.6
Control of chronic respiratory disease (CRD) and air sac infections caused by Mycoplasma gallisepticum and Escherichia coli, susceptible to oxytetracycline.400 - 800 mg   12.6 - 6.3 
Control of fowl cholera caused by Pasteurella multocida, susceptible to oxytetracycline.400 - 800 mg    12.6 - 6.3
 T
 U
 R
 K
 E
 Y
 S
Control of hexamitiasis caused by Hexamita meleagridis, susceptible to oxytetracycline.  200 - 400 mg    25.3 - 12.6
Control of infectious synovitis caused by Mycoplasma synoviae, susceptible to oxytetracycline.   400 mg      12.6
GROWING TURKEYS — Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis), susceptible to oxytetracycline.   25 mg/lb
 body weight
Varies with age &
water consumption
 S
 W
 I 
 N
 E
FOR THE CONTROL AND TREATMENT OF THE FOLLOWING DISEASES IN SWINE –
Bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis, susceptible to oxytetracycline.
Bacterial pneumonia caused by Pasteurella multocida, susceptible to oxytetracycline.
FOR BREEDING SWINE: Leptospirosis (reducing the incidence of abortions and shedding of leptospira)
caused by Leptospira pomona, susceptible to oxytetracycline.
    10 mg/lb
   body weight
Varies with age &
water consumption


1400 Gram Front Panel



Oxytet® Soluble

(oxytetracycline hydrochloride soluble powder)
Antibiotic

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

This packet contains 512 g of oxytetracycline hydrochloride and will make:

2560 gallons (9690 liters) containing 200 mg oxytetracycline hydrochloride per gallon
1280 gallons (4845 liters) containing 400 mg oxytetracycline hydrochloride per gallon
640 gallons (2422 liters) containing 800 mg oxytetracycline hydrochloride per gallon

               This packet will treat 51,200 lbs of swine.
This packet will treat 20,480 lbs of turkey at 25 mg/lb body weight.

RECOMMENDED PACKET
STORAGE CONDITIONS:
Store between 20°C - 25°C
(68°F - 77°F) with excursions
permitted between 15°C - 40°C
(59°F - 104°F).
See back panel for
instructions.


Net Weight
3.09 lbs (1400 g)

For Use in Drinking Water Only 

Not For Use in Liquid Medicated Feeds

Not For Use in Humans 

Keep Out of Reach of Children

HAZARDOUS REMEDY

Restricted Drug (California) - Use
only as directed.

HUVEPHARMA®

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

HUVEPHARMA and Oxytet
are registered trademarks of
Huvepharma EOOD

13924800 Rev. 02-2021
Approved by FDA under NADA #130-435


Caution:



Use as the sole source of oxytetracycline. Not to be used for more than 5 consecutive days in swine or 14
consecutive days in chickens and turkeys.

Use as the sole source of oxytetracycline. Not to be used for more than 5 consecutive days in swine or 14
consecutive days in chickens and turkeys.


1772 Gram Front Panel



Oxytet® Soluble

(oxytetracycline hydrochloride soluble powder)
Antibiotic

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

      This packet contains 648 g of oxytetracycline hydrochloride and will make:

3240 gallons (12,265 liters) containing 200 mg oxytetracycline hydrochloride per gallon
1620 gallons (6,132 liters) containing 400 mg oxytetracycline hydrochloride per gallon
810 gallons (3,066 liters) containing 800 mg oxytetracycline hydrochloride per gallon

                     This packet will treat 64,800 lbs of swine.
   This packet will treat 25,920 lbs of turkey at 25 mg/lb body weight.

RECOMMENDED PACKET
STORAGE CONDITIONS:
Store between 20°C - 25°C
(68°F - 77°F) with excursions
permitted between 15°C - 40°C
(59°F - 104°F).

See back panel for
instructions.

Net Weight
3.91 lbs (1772 g)

For Use in Drinking Water Only 

Not For Use in Liquid Medicated Feeds

Not For Use in Humans 

Keep Out of Reach of Children

HAZARDOUS REMEDY

Restricted Drug (California) - Use
only as directed.

HUVEPHARMA®

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

HUVEPHARMA and Oxytet
are registered trademarks of
Huvepharma EOOD. 

13925200 (Rev. 02-2021)
Approved by FDA under #130-435


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