Animal NDC 23243-9561-5 Amprol 25

Amprolium

Animal NDC Product Code 23243-9561-5

Field Name Field Value
Animal NDC Code 23243-9561-5
Proprietary Name Amprol 25 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 Amprolium 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
Active Ingredient(s)
  • Amprolium
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 NADA012350 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.

Amprol 25 Animal Product Label Images

Amprol 25 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.

Product Labeling Index

Other

BAG FRONTNADA 12-350                                                            Product 956150 Approved by FDAAMPROL 25% (amprolium)Type A Medicated ArticleAMPROL (amprolium) 25% is intended for use in (1) preventing outbreaks of coccidiosis in growing chickens, turkeys and pheasants and (2) development of active immunity to coccidiosis in replacement chickens. AMPROL 25% is also intended for use in the prevention and treatment of coccidiosis in laying chickens.ACTIVE DRUG INGREDIENT: Amprolium ......25%INGREDIENTS: Corn Gluten Feed and Soybean OilSEE DIRECTIONS ON BACK PANEL Manufactured by:                                                                   Huvepharma, Inc. Huvepharma, Inc., St. Louis, MO 63116                                   525 Westpark Drive, Suite 230                                                                                              Peachtree City, GA 30269 Distributed by: Huvepharma, Inc., Peachtree City, GA 30269 For questions, call 1-877-4AMPROL AMPROL is a registered trademark of Huvepharma, Inc.Net Wt.:   50 lb (22.68 kg)

Bag Back Panel

Take Time Image

Warnings And Precautions

WARNINGKeep this and all drugs out of the reach of children.The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, obtainan MSDS or for assistance, contact Huvepharma at 1-877-4AMPROL.

Dosage & Administration

MIXING DIRECTIONSAMPROL (amprolium) 25% should be thoroughly and evenly mixed in the feed. AMPROL 25% may be used to manufacture a Type C medicated feed in the concentration range 0f 0.004% to 0.025%. The table below shows the amount of AMPROL 25% to be used in each ton (2000 lb) of feed to obtain desired levels of amprolium in the Type C medicated feed. To aid in even distribution of AMPROL 25% in the finished feed, prepare a mixture of AMPROL 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.Feeding level of AmproliumIn Type C Medicated FeedsUse This Amount ofAMPROL 25% Per Ton0.004%5 oz0.006%8 oz0.008%10 oz0.0125%1 lb0.0175%1 lb 6 ½ oz0.025%2 lbAMOUNT AND DIRECTIONS FOR USE CHICKENSBroilersPreventionUse 0.0125% amprolium Type C medicated feed continuously for most field conditions as they exist under modern management practices. Where severe coccidiosis conditions exists and where immunity is not required, use 0.025% amprolium Type C medicated feed. For field      conditions where only E. tenella is the major problem, use 0.008%-0.0125% amprolium Type C medicated feed.Increasing levels of amprolium may not prevent coccidiosis caused by strains of Eimeria commonly found to be resistant to Amprolium.Replacements:Immunity Development or PreventionPrevention Program:Where immunity development is not desirable, use 0.0125% -0.025% amprolium Type C medicated feed continuously from day old until onset of productionImmunity DevelopmentProgram:Use 0.004%-0.0125%ampfolium Type C medicated feed continuously until onset of productionSelection of the level to be used should be based upon comparative hazard of infection with cecal and intestinal species. The higher levels will interfere with the development immunity to E. tenella (cecal).The following are suggested feeding schedules for various conditions of coccidial exposure. The planning and evaluation of any program should be in the hands of a veterinarian or poultry pathologist who is familiar with the specific operation and with the general nature of disease problems in the area.1. Severe exposure     2. Moderate exposure3. Slight exposure0-5 weeks of age 0.0125% 0-5 weeks of age 0.008%-0.0125%0-5 weeks of age 0.004%-0.0125%5-8 weeks of age 0.008%-0.0125%5-8 weeks of age 0.006%-0.0125% 5-8 weeks of age 0.004%-0.0125%over 8 weeks of age 0.004%-0.0125%over 8 weeks of age 0.004%-0.0125%over 8 weeks of age 0.004%-0.0125%LAYING CHICKENS:Treatment:Use 0.025% amprolium Type C medicated feed for two weeks in severe outbreaks or 0.0125% amprolium Type C medicated feed for two weeks in moderate outbreaks.PreventionUse 0.0125% amprolium Type C medicated feed continuously.TURKEYS:PreventionUse 0.0125%-0.025% amprolium Type C medicated feed continuously.PHEASANTS:For the prevention of coccidiosis in growing pheasants caused by Eimeria colchici, E. duodenalis, and E. phasiani.Type C medicated feed with 0.0175% amprolium should be fed continuously as the sole ration.

General Precautions

CAUTION:Use as the sole source of amprolium.Do not change the litter while giving this feed unless absolutely necessary.If losses exceed 0.5% in a 2-day period, obtain an accurate diagnosis, and follow the instructions of your veterinarian or poultry pathologist.Losses may result from intercurrent disease or other conditions affecting drug intake which can contribute to the virulence of coccidiosis under field conditions.In replacement flocks the grower must expect that excessive exposure to one or more species may overwhelm the drug in some flocks and prompt treatment will be required.Fertility, hatchability and other reproductive data are not available on amprolium in breeding pheasants.Do not use in feeds containing bentonite.Restricted Drug (California) Use Only as Directed.

Storage And Handling

STORAGE: Store at or below 25°C (77°F), excursions permitted to 40°C (104°F).Avoid prolonged exposure to high humidity.

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

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