Animal NDC 54771-8728-1 Actogain

Ractopamine Hydrochloride

Animal NDC Product Code 54771-8728-1

Field Name Field Value
Animal NDC Code 54771-8728-1
Proprietary Name Actogain 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 Ractopamine Hydrochloride 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
Active Ingredient(s)
  • Ractopamine Hydrochloride
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • SOYBEAN OIL (241ATL177A)
  • WATER (059QF0KO0R)
  • SOYBEAN OIL (241ATL177A)
Marketing Category ANADA - ABBREVIATED 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 ANADA200548 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.

Actogain Animal Product Label Images

Actogain 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

Complete Feed

Indications Appropriate Concentration of Ractopamine in Type C Medicated FeedBased on 90% Dry Matter Basis Ractopamine (mg/hd/d) Increased Rate of Weight Gain, and Improved Feed Efficiency 8.2 to 24.6 g/ton (9 to 27 ppm) 70-430 Increased Rate of Weight Gain, Improved Feed Efficiency, and Increased Carcass Leanness 9.8 to 24.6 g/ton (11 to 27 ppm) 90-430 Carcass Measurements Effect of Ractopaminea 8.2 grams/ton (9 ppm) 16.4 grams/ton (18 ppm) 24.6 grams/ton (27 ppm)a The effect of ractopamine on parameters listed in this table is supported by data generated at the doses tested in the clinical field efficacy trials.NC= No Change, ↑= increased, ↓ = decreasedb Steers Onlyc Reduction indicates an improvement in USDA Yield Grade. Hot Carcass Weight, lbs ↑ ↑ ↑ Dressing Percentage, % NC ↑b ↑b Carcass Percent Fat, % NC ↓ ↓ 12th Rib Fat Thickness, in. NC NC NC Average Rib Eye Area, sq. in. ↑ ↑ ↑ USDA Yield Grade NC NC ↓c Marbling Score NC NC NC Rate of Carcass Lean Gain per Day NC ↑ ↑ Efficiency of Carcass Lean Gain per Day NC ↑ ↑

Top Dress Feed

Indications Appropriate Concentration of Ractopamine in Type C Medicated Feeda Ractopamine (mg/hd/d) Increased Rate of Weight Gain and Improved Feed Efficiency Appropriate Concentration of Ractopamine in a minimum of 1.0 lb Top Dressed Type C Medicated Feeda (maximum of 800 g/ton) 70-400aBased on 90% Dry Matter BasisInert Ingredients: Ground corncobs.

Mixing Directions (Complete Feed)

Thoroughly mix Actogain 45 Type A Medicated Article in a ton of appropriate feed ingredients or diluents according to the table below to obtain the proper concentration in the Type B Medicated Feed (maximum 4,920 g/ton). The following table gives examples of how some Type B Medicated Feed concentrations can be prepared: Pounds of Actogain 45a to Add per Ton To Make a Type B Medicated Feed Resulting Ractopamine Concentration in Type B Medicated Feedb grams/ton grams/pound 36.1 1,640 0.82 72.2 3,280 1.64 108.3 4,920 2.46a Actogain 45 contains 45.4g ractopamine hydrochloride per poundb Based on 90% Dry Matter BasisThoroughly mix Actogain 45 Type A Medicated Article in a ton of complete cattle feed according to the table below to obtain the proper concentration in the Type C Medicated Feed. Prepare an intermediate pre-blend of the premix prior to mixing in a complete feed. Thoroughly mix the required amount in a convenient quantity of feed ingredients then add to the remaining feed ingredients to make one ton of complete feed. Pounds of Actogain 45a to Add per Ton To Make a Type C Medicated Feed Resulting Ractopamine Concentration in Type C Medicated Feedb 0.18 8.2 grams/ton (9 ppm) 0.36 16.4 grams/ton (18 ppm) 0.54 24.6 grams/ton (27 ppm)a Actogain 45 contains 45.4g ractopamine hydrochloride per poundb Based on 90% Dry Matter Basis

Mixing Directions (Liquid Type B Feeds)

Thoroughly mix Actogain 45 Type A Medicated Article in a ton of appropriate feed ingredients or diluents according to the table below to obtain the proper concentration in the Type B Medicated Feed (maximum 2300 g/ton).Maintain supplement pH to 4.5 to 7.5. For stored liquid Type B medicated feeds containing ractopamine, recirculate immediately prior to use for not less than 10 minutes, moving not less than 1% of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not in use.The following table gives examples of how some Type B Medicated Feed concentrations can be prepared: Pounds of Actogain 45a to Add per Ton To Make a Liquid Type B Medicated Feed Resulting Ractopamine Concentration in Liquid Type B Medicated Feed grams/ton grams/pound 36.1 1,640 0.82 44.1 2,000 1.00 50.7 2,300 1.15a Actogain 45 contains 45.4g ractopamine hydrochloride per pound

Mixing Directions For Preparing Type C Medicated Top Dress Feed

Thoroughly mix Actogain 45 Type A Medicated Article in a ton of appropriate feed ingredients or diluents according to the table below to obtain the proper concentration in the Type C Medicated Feed (maximum 800 g/ton). The following table gives examples of how some Type C Medicated Top Dress Feed concentrations can be prepared: Pounds of Actogain 45a to Add per Ton To Make a Type C Medicated Top Dress Feed Resulting Ractopamine Concentration in Type C Medicated Top Dress Feedb Top Dress grams/ton grams/pound mg/pound 2.20 100 0.05 50 4.41 200 0.10 100 6.61 300 0.15 150 8.81 400 0.20 200 17.62 800 0.40 400a Actogain 45 contains 45.4g ractopamine hydrochloride per poundb Based on 90% Dry Matter Basis

Caution

Not for animals intended for breeding.NOT FOR HUMAN USE

Warning

The active ingredient in Actogain, ractopamine hydrochloride, is a beta-adrenergic agonist. Individuals with cardiovascular disease should exercise special caution to avoid exposure. Not for use in humans. Keep out of the reach of children. The Actogain 45 formulation (Type A Medicated Article) poses a low dust potential under usual conditions of handling and mixing. When mixing and handling Actogain, use protective clothing, impervious gloves, protective eye wear, and a NIOSH-approved dust mask. Operators should wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse eyes thoroughly with water. If irritation persists, seek medical attention. The material safety data sheet contains more detailed occupational safety information. To report adverse effects, access medical information, or obtain additional product information, call 1-888-963-8471.

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