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Animal NDC 23243-6807-5 Bio-cox Type A Medicated Article

Salinomycin Sodium

Animal Product Information

Field Name Field Value
Animal NDC Code 23243-6807-5
Proprietary Name Bio-cox Type A Medicated Article 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 Salinomycin Sodium 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 Otc Type A Medicated Article Animal Drug
Usage Information
    Broiler chickens and replacement chickensUse Bio-Cox Type A Medicated Article to provide salinomycin sodiumconcentrations ranging from 40-60 g/ton (0.0044% to 0.0066%) for theprevention of coccidiosis in broiler chickens and replacement chickenscaused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunettiand E. mivati. The dosage should be adjusted to meet the severity of thecoccidial challenge, which varies with environmental and managmentconditions.QuailUse Bio-Cox Type A Medicated Article to provide salinomycin sodiumconcentrations of 50 g/ton (0.0055%) for the prevention of coccidiosis inquail caused by Eimeria dispersa and E. lettyae.
Active Ingredient(s)
  • Salinomycin Sodium
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 NADA128686 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.

Bio-cox Type A Medicated Article Images

Bio-cox Type A Medicated Article 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



Other



Bio-Cox®

Type A Medicated Article

Brand of Salinomycin Sodium
Type A Medicated Article

Net wt 50 LB (22.68 kg)

HUVEPHARMA®

HUVEPHARMA®

Distributed by:
Huvepharma, Inc.
Peachtree City, GA 30269

HUVEPHARMA and Bio-Cox are registered trademarks of Huvepharma EOOD.

Made in USA

Net wt 50 LB (22.68 kg)


Dosage & Administration



Bio-Cox®
Type A Medicated Article

Brand of Salinomycin Sodium
Type A Medicated Article

For use in broiler chickens, replacement chickens, and quail only

Active drug ingredient

Salinomycin equivalent to 60 grams salinomycin sodium activity per pound

For use in manufacturing medicated feeds only


Veterinary Indications



Broiler chickens and replacement chickens

Use Bio-Cox Type A Medicated Article to provide salinomycin sodium
concentrations ranging from 40-60 g/ton (0.0044% to 0.0066%) for the
prevention of coccidiosis in broiler chickens and replacement chickens
caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti
and E. mivati. The dosage should be adjusted to meet the severity of the
coccidial challenge, which varies with environmental and managment
conditions.

Quail

Use Bio-Cox Type A Medicated Article to provide salinomycin sodium
concentrations of 50 g/ton (0.0055%) for the prevention of coccidiosis in
quail caused by Eimeria dispersa and E. lettyae.


Indications & Usage



Mixing directions

Thoroughly mix Bio-Cox Type A Medicated Article with non-medicated feed
to provide the level of salinomycin sodium per ton as indicated in the table below.

Salinomycin Sodium ActivityAmount of Bio-Cox 
Type A Medicated Article (60 g/lb)
Per Ton of Feed
(grams per ton) lbgrams 

40

45

50

55

60

0.67

0.75

0.83

0.92

1.00 

304

341

377

418

454

Feeding directions

Feed continuously as the sole ration

Important

Must be thoroughly mixed in feeds before use. Not approved for use with
pellet binders.


Precautions



Caution

May be fatal if accidentally fed to adult turkeys or to horses.


Warnings



Warning

Do not feed to birds producing eggs for human consumption.
When mixing and handling Bio-Cox Type A Medicated Article
premix, use protective clothing, impervious gloves, eye protection,
and an approved dust respirator. Operators should wash thoroughly
with soap and water after handling. If accidental eye contact
occurs, immediately rinse thoroughly with water.


Storage And Handling



Store below 25°C (77°F), excursions permitted to 37°C (99°F)
Restricted drug (California) - Use only as directed. Not for human use.
Approved by FDA under NADA # 128-686


Package Label.Principal Display Panel




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