Animal NDC 54771-1116-1 Zoamix

Dinitolmide

Animal Product Information

Field Name Field Value
Animal NDC Code 54771-1116-1
Proprietary Name Zoamix 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 Dinitolmide 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 Otc Type A Medicated Article Animal Drug
Usage Information
    Broiler Chickens: For prevention and control of coccidiosisReplacement Chickens: For development of active immunity to coccidiosisGrowing Turkeys: For prevention and control of coccidiosis
Active Ingredient(s)
  • Dinitolmide
Inactive Ingredient(s)
  • MINERAL OIL (T5L8T28FGP)
  • MINERAL OIL (T5L8T28FGP)
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 NADA011116 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.

Zoamix 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



Indications



Broiler Chickens: For prevention and control of coccidiosis

Replacement Chickens: For development of active immunity to coccidiosis

Growing Turkeys: For prevention and control of coccidiosis


Directions



It is suggested that a mixture of Zoamix and some feed ingredient be prepared prior to mixing in with the finished ration. This will ensure thorough and even distribution in the feed.


For Chickens Grown For Meat Purposes:



Use 1 lb (454 g) of Zoamix per 2,000 lb (909 kg) of finished product to produce a feed containing 0.0125% zoalene. Zoamix should be thoroughly blended into the finished feed. Feed containing zoalene should be fed continuously as the only ration from the time chicks are placed in floor pens until they are slaughtered for meat.


For Replacement Chickens:



Feed containing zoalene can be used in a program to raise replacement birds. When used under conditions of exposure to coccidiosis, it will allow immunity to develop adequately to protect against losses due to the disease when the birds are placed on nonmedicated feed for egg laying purposes. The following chart outlines the type of feeding program to follow where complete formulated feed is the sole ration:

Starter ration

Grower ration*

Growing condition

% Zoalene per ton

Zoamix to be added per ton of feed

% Zoalene in feed

Zoamix to be added per ton of feed

(lb)

(g)

(lb)

(g)

Severe exposure to coccidiosis expected

0.0125

1

454

0.0083 to 0.0125

2/3 to 1

303 to 454

Light to moderate exposure to coccidiosis expected

0.0083 to 0.0125

2/3 to 1

303 to 454

0.004 to 0.0083

1/3 to 2/3

151 to 303

 * Grower ration not to be fed to birds over 14 weeks of age.


For Turkeys Grown For Meat Purposes Only:



When turkey poults are reared in confinement and severe exposure to coccidiosis is usually a problem, use 1½ lb (681 g) of Zoamix per ton (2,000 lb) of feed to produce a finished feed containing 0.0187% zoalene. Under the usual conditions of rearing turkey poults, or when turkey poults are on range, use 1 lb (454 g) of Zoamix per 2,000 lbs (909 kg) of feed to produce a finished feed containing 0.0125% zoalene. The feed containing zoalene should be fed continuously until the birds are 14 to 16 weeks of age.


Combinations With Other Drugs



Use only in accordance with the current New Animal Drug Regulation for zoalene, Section 558.680 of the Regulations promulgated under the Federal Food, Drug and Cosmetic Act.


Cautions



Not to be fed to laying birds.

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

Avoid inhaling dust.

Avoid contact with eyes.


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