Animal NDC 66104-8200-0 Nicarb

Nicarbazin

Animal Product Information

Field Name Field Value
Animal NDC Code 66104-8200-0
Proprietary Name Nicarb 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 Nicarbazin 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 Phibro Animal Health
Product Type Otc Type A Medicated Article Animal Drug
Usage Information
    As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix,and E. brunetti) coccidiosis in chickens.
Active Ingredient(s)
  • Nicarbazin
Inactive Ingredient(s)
  • SOYBEAN OIL (241ATL177A)
  • WHEAT MIDDLINGS (12H8QE0WQI)
  • SOYBEAN OIL (241ATL177A)
  • WHEAT MIDDLINGS (12H8QE0WQI)
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 NADA009476 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.

Nicarb Images

Nicarb 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 & Usage



As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix,and E. brunetti) coccidiosis in chickens.


Active Drug Ingredient



Nicarbazin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25%


Ingredients



Wheat Middlings, Soybean Oil and Microtracer


Mixing Directions



NICARB (nicarbazin) 25% should be thoroughly and evenly mixed in the feed in accordance with current good manufacturing practice for feed. Type C medicated feeds should contain 0.01 – 0.02% nicarbazin. Uniformly mix 0.8 – 1.6 pounds of Nicarb 25% with one of the feed ingredients to make at least 10 pounds of premix before final mixing. Mix the resulting premix with feed to make 1 ton (2000 lb) of finished feed containing 0.01 – 0.02% nicarbazin.

SUGGESTED DIRECTIONS FOR FEED TAGS

Use Directions

Use Nicarbazin Type C medicated feed as the only ration from the time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard.


Caution:



Do not feed to laying chickens.

Do not use as a treatment for outbreaks of coccidiosis. Do not use in flushing mashes.

If losses exceed 0.5 percent in a 2-day period, obtain an accurate diagnosis and follow the instructions of your veterinarian or poultry pathologist.

Broilers fed feed medicated with NICARB 25% may show reduced heat tolerance when exposed to high temperature and high humidity to which they have not been accustomed and under severe conditions, fatalities may result. An ample supply of drinking water and adequate ventilation will improve the birds’ tolerance of heat.


Warning:



Withdraw 4 days before slaughter when used at levels ≤ 0.0125%.

Withdraw 5 days before slaughter when used at levels >0.0125%

Keep this and all drugs out of the reach of children.

NOT FOR HUMAN USE

RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED


Other



SEE DIRECTIONS ON BACK PANEL

Net Wt 50 lb (22.68 kg)

8205000

101-9018-13

Approved by FDA under NADA  #009-476

NICARB REG TM Phibro Animal Health Corporation

MICROTRACER REG TM Micro-Tracers, Inc. San Francisco, CA


Generic Section



Distributed by:

Phibro Animal Health Corporation, Teaneck, NJ 07666


Nicarb 25 Label



Nicarb Label


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