Animal NDC 23243-9709-3 Amprol 128

Amprolium

Animal NDC Product Code 23243-9709-3

Field Name Field Value
Animal NDC Code 23243-9709-3
Proprietary Name Amprol 128 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 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 NADA033165 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 128 Animal Product Label Images

Amprol 128 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

Indications

AMPROL 128 (amprolium) 20% Soluble Powder is intended for the treatment of coccidiosis in growing chickens, turkeys and laying hens.

Caution

If no improvement is noted within 3 days, have the diagnosis confirmed 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.

Storage:

Store between 5o - 25oC (41o - 77oF) with brief excursions to 40oC (104oF). Avoid high humidity storage conditions.

Use Directions:

Give amprolium at the 0.012% level (10 oz AMPROL 128 20% Soluble Powder per 128 Gallons) as soon as coccidiosis is diagnosed and continue for three to five days. (In severe outbreaks, give amprolium at the 0.024% level.) Continue with 0.006% amprolium medicated water for an additional 1 to 2 weeks. No other source of drinking water should be available to the birds during this time.Use as the sole source of amprolium.

Mixing And Dosage Administration

PREMEASURED FOR AUTOMATICWATER PROPORTIONERSFor Automatic Water ProportionersFor use in automatic water proportioners that meter1 fluid ounce of stock solution per gallon of drinkingwater.                                          Dissolve AMPROL 128                                   (amprolium) 20% Soluble PowderTo prepare                       In one gallon of waterdosage levels of:       (Makes 1 gallon of stock solution)0.024%                                        2 bags (20 oz) in 1 gallon0.012%                                        1 bag (10 oz) in 1 gallon0.006%                                       1/2 bag (5oz) in 1 gallonTo Prepare 50 Gallons of Medicated WaterDOSAGE LEVEL           MIXING DIRECTIONS0.024%                        Dissolve 8 ounces of AMPROL 128                                   20% SOLUBLE POWDER in about 5                                   gallons of water in a 50-gallon                                   medicated barrel. Stir, then add                                   water to the 50-gallon mark.                                   Stir thoroughly.0.012%                        Follow same directions as above but                                   use 4 ounces of AMPROL 128 20%                                   SOLUBLE POWDER.0.006%                        Follow same directions as above but                                   use 2 ounces of AMPROL 128 20%                                   SOLUBLE POWDER.

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