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 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 RactopamineThe effect of ractopamine on parameters listed in this table is supported by data generated at the doses tested in the clinical field efficacy trials. 8.2 grams/ton (9 ppm) 16.4 grams/ton (18 ppm) 24.6 grams/ton (27 ppm) NC= No Change, ↑= increased, ↓ = decreased Hot Carcass Weight, lbs ↑ ↑ ↑ Dressing Percentage, % NC ↑Steers Only ↑ Carcass Percent Fat, % NC ↓ ↓ 12th Rib Fat Thickness, in. NC NC NC Average Rib Eye Area, sq. in. ↑ ↑ ↑ USDA Yield Grade NC NC ↓Reduction indicates an improvement in USDA Yield Grade. 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 FeedBased on 90% Dry Matter Basis 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 Feed (maximum of 800 g/ton) 70-400Inert Ingredients: Ground corncobs.

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