Animal NDC 23243-5278-5 Ravantage 45
Ractopamine Hydrochloride
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 23243-5278-5 |
| Proprietary Name | Ravantage 45 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 | Huvepharma, Inc |
| Product Type | Otc Type A Medicated Article Animal Drug |
| Usage Information |
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| Active Ingredient(s) |
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| Inactive Ingredient(s) |
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| 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 | ANADA200768 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. |
Ravantage 45 Images
Ravantage 45 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
Other
Huvepharma®
Ravantage® 45
(ractopamine hydrochloride Type A medicated article)
For Use in Finishing Swine Feeds Only
Net Weight 25 lbs
(11.34 kg)
Do not feed undiluted. |
Mixing Directions: Thoroughly mix Ravantage 45 Type A Medicated Article into one ton of appropriate feed ingredients according to the table below to obtain the proper concentration in the Type B Medicated Feed (maximum 4920 g/ton).
The following table gives examples of how some Type B Medicated Feed concentrations can be prepared:
Pounds of Ravantage 45 To Add | Resulting Ractopamine Concentration | |
Grams/ton | Grams/pound | |
19.82 | 900 | 0.45 |
39.65 | 1,800 | 0.90 |
59.47 | 2,700 | 1.35 |
79.30 | 3,600 | 1.80 |
Thoroughly mix Ravantage 45 Type A Medicated Article into one ton of complete swine feed according to the table below to obtain the proper concentration in the Type C Medicated Feed. Prepare at least one 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 a ton of complete feed.
Pounds of Ravantage 45 To Add Per | Resulting Ractopamine |
0.10 | 4.5 grams/ton (5 ppm) |
0.20 | 9 grams/ton (10 ppm) |
Otc - Active Ingredient
Active Drug Ingredient: ractopamine hydrochloride - 45.4 g per lb (100 g per kg)
Important: Must be thoroughly mixed into feeds before use. Follow label directions.
Indications & Usage
Indication: For increased rate of weight gain, improved feed efficiency and increased carcass leanness in finishing swine, weighing not less than 150 lbs, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lbs of gain prior to slaughter.
Appropriate Concentration of Ractopamine in Type C |
4.5 to 9.0 g/ton* |
Inert Ingredients: Ground corncobs.
| NC = No Change, ↑ = increased, ↓ = decreased, | ||||
| a Improvement was observed only in pigs weighing less than 250 lbs. | ||||
Variable | Last 45 lbs of | Last 90 lbs of | ||
4.5 g/ton | 9.0 g/ton | 4.5 g/ton | 9.0 g/ton | |
Carcass Fat | ↓a | ↓a | ↓ | ↓ |
10th Rib Backfat (3/4 location) | NC | NC | NC | ↓ |
Last Rib Backfat (midline) | NC | NC | NC | NC |
Loin Eye Area (10th Rib) | ↑a | ↑ | ↑ | ↑ |
Rate of Lean Gain | ↑ | ↑ | ↑ | ↑ |
Efficiency of Lean Gain | ↑ | ↑ | ↑ | ↑ |
Dressing Percentage | NC | ↑ | ↑ | ↑ |
Dosage & Administration
Feeding Directions: Feed continuously as the sole ration to finishing swine weighing not less than 150 lbs for the last 45 to 90 lbs (group average) of weight gain prior to slaughter.
CAUTION: Ractopamine may increase the number of injured and/or fatigued pigs during marketing.
Not for use in breeding swine.
Boxed Warning Section
WARNING: The active ingredient in Ravantage 45, 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 Ravantage 45 formulation (Type A Medicated Article) poses a low dust potential under usual conditions of handling and mixing. When mixing and handling Ravantage 45, 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 suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet, contact Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.
Storage And Handling
Storage information: Store at less than or equal to 25°C (77°F)
Excursions to 30°C (86°F) are acceptable. Avoid excessive moisture.
Expiration Date and Lot Number are printed on the bag.
Not to be used after the expiry date.
Restricted Drug (California) - Use Only as Directed
Approved by FDA under ANADA # 200-768
Ravantage® 45
Manufactured for: Huvepharma, Inc.
525 Westpark Drive, Ste 230, Peachtree City, GA 30269, U.S.A.
To report adverse effects, access medical information, or obtain additional product information, call 1-877-994-4883.
HUVEPHARMA and Ravantage are trademarks owned or licensed by HUVEPHARMA EOOD, its subsidiaries or affiliates.
Made in Bulgaria.
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.
