Animal NDC 23243-9568-5 Coyden Type A Medicated Article

Clopidol

Animal Product Information

Field Name Field Value
Animal NDC Code 23243-9568-5
Proprietary Name Coyden 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 Clopidol 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/REPLACEMENT CHICKENS:As an aid in the prevention of cecal and intestinal cocciodiosis caused by E. tenella, E. necatrix,E. acervulina, E. maxima, E. brunetti, E. mivati.TURKEYS:As an aid in the prevention of leucocytozoonosis caused by Leucocytozoon smithi.SEE DIRECTIONS ON BACK PANELFOR THE MANUFACTURE OF COMPLETE FEEDS ONLY. INDICATIONS FOR USE:BROILER AND REPLACEMENT CHICKENSAs an aid in the prevention of coccidiosis in broilers and replacements for caged layers caused byE. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati.TURKEYS GROWN FOR MEAT PURPOSES ONLYAs an aid in the prevention of leucocytozoonosis caused by Leucocytozoon smithi.
Active Ingredient(s)
  • Clopidol
Inactive Ingredient(s)
  • MINERAL OIL (T5L8T28FGP)
  • RICE BRAN (R60QEP13IC)
  • MINERAL OIL (T5L8T28FGP)
  • RICE BRAN (R60QEP13IC)
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 NADA034393 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.

Coyden 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



Approved by the FDA under NADA # 034-393

COYDEN® 25%
(clopidol)
Type A Medicated Article

Manufactured by:
HUVEPHARMA, Inc. Peachtree City, GA 30269             Huvepharma, Inc.
                                                                              525 Westpark Drive, Suite 230
Distributed by:                                                         Peachtree City, GA 30269
HUVEPHARMA, Inc. Peachtree City, GA 30269

For questions, call 1-877-994-4883

® COYDEN is a registered trademark of Huvepharma, Inc.

Net Wt.: 50 lb (22.68 kg)


Otc - Active Ingredient



ACTIVE DRUG INGREDIENT: Clopidol.................................113.5 gm/lb (25%)


Inactive Ingredient



INGREDIENTS: Rice Hulls, Mineral Oil, Fatty Acid Glycerides


Indications & Usage



BROILER/REPLACEMENT CHICKENS:
As an aid in the prevention of cecal and intestinal cocciodiosis caused by E. tenella, E. necatrix,
E. acervulina, E. maxima, E. brunetti, E. mivati.

TURKEYS:
As an aid in the prevention of leucocytozoonosis caused by Leucocytozoon smithi.

SEE DIRECTIONS ON BACK PANEL

FOR THE MANUFACTURE OF COMPLETE FEEDS ONLY.

INDICATIONS FOR USE:
BROILER AND REPLACEMENT CHICKENS
As an aid in the prevention of coccidiosis in broilers and replacements for caged layers caused by
E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati.

TURKEYS GROWN FOR MEAT PURPOSES ONLY
As an aid in the prevention of leucocytozoonosis caused by Leucocytozoon smithi.


User Safety Warnings



USER SAFETY WARNING:
Not for Human Use. Keep Out of Reach of Children.
Contact Huvepharma Inc. at 1-877-994-4883 or http://www.huvepharma.us. For additional
information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or
http://www.fda.gov/reportanimalae.

Restricted Drug (California)
Use only as Directed


Residue Warning



                     WITHDRAWAL PERIODS AND RESIDUE WARNINGS:
CHICKENS: When feeding 0.025% clopidol, reduce dosage to 0.0125% or withdraw
medication 5 days before slaughter. Do not feed to chickens over 16 weeks of age.
TURKEYS: Withdraw medication 5 days before slaughter.


General Precautions



CAUTION: Consult a veterinarian or poultry pathologist if losses exceed 0.5% in a 2-day period.


Dosage & Administration



MIXING DIRECTIONS:
For Complete Rations - Type C Medicated Products
COYDEN® 25% (clopidol) should be thoroughly and evenly mixed in the feed in accordance with
current good manufacturing practice for medicated feed. COYDEN 25% may be used to manufacture
a Type C medicated feed in the concentration range of 0.0125% to 0.025% clopidol.

To aid in even distribution of COYDEN 25% in the finished feed, prepare a mixture of COYDEN 25% in
a portion of complete feed ingredient before mixing into the finished ration. Blend the mixture with
the remainder of the finished feed and mix thoroughly.

DIRECTIONS FOR USE:
Must be mixed with other ingredients before feeding.
Mixing and conveying equipment should be properly grounded.
Use 1 pound of COYDEN 25% per ton of feed to produce a feed containing 0.0125% clopidol.
Use 2 pounds of COYDEN 25% per ton of feed to produce a feed containing 0.025% clopidol.

FEEDING DIRECTIONS:
Feed continuously, as the sole ration, either the 0.0125% or 0.025% Type C medicated feed
depending upon management practices, degree of exposure, and amount of feed eaten.


Storage And Handling



STORE IN A COOL PLACE
KEEP BAG TIGHTLY CLOSED


Package Label.Principal Display Panel




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