Animal NDC 58198-0602-9 Paylean 9
Ractopamine Hydrochloride
Animal Product Information
Field Name | Field Value |
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Animal NDC Code | 58198-0602-9 |
Proprietary Name | Paylean 9 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 | Elanco Us Inc. |
Product Type | Vfd Type A Medicated Article Animal Drug |
Usage Information |
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Active Ingredient(s) |
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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 | NADA140863 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. |
Paylean 9 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
Elanco™
AF0602
Paylean™9
(ractopamine hydrochloride
Type A medicated article)
For Use in Finishing Swine Feeds Only
Do not feed undiluted. |
Net Weight 25 lbs
(11.34 kg)
Active Drug Ingredient: ractopamine hydrochloride - 9 g per lb (20 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* |
(5 to 10 ppm) |
* No increased benefit has been shown when ractopamine concentrations in the diet are greater than 4.5 g/ton (5 ppm). |
Inert Ingredients: Ground corncobs.
NC = No Change, ↑ = increased, ↓ = decreased, | |||||
a Improvement was observed only in pigs weighing less than 250 lbs. | |||||
Last 45 lbs of body weight gain | Last 90 lbs of body weight gain | ||||
Variable | 4.5 g/ton ractopamine | 9.0 g/ton ractopamine | 4.5 g/ton ractopamine | 9.0 g/ton ractopamine | |
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
Mixing Directions: Thoroughly mix Paylean 9 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 Paylean 9 To Add Per Ton | Resulting Ractopamine Concentration in Type B Medicated Feed | |
grams/ton | grams/pound | |
100 | 900 | 0.45 |
200 | 1,800 | 0.90 |
300 | 2,700 | 1.35 |
400 | 3,600 | 1.80 |
Thoroughly mix Paylean 9 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 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 a ton of complete feed.
Pounds of Paylean 9 To Add | Resulting Ractopamine Concentration |
0.5 | 4.5 grams/ton (5 ppm) |
1.0 | 9 grams/ton (10 ppm) |
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.
NOT FOR HUMAN USE
Storage And Handling
Storage information: Store at less than or equal to 25°C (77°F).
Excursions to 40°C (104°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 NADA # 140-863.
Manufactured for: Elanco US, Inc
Greenfield, IN 46140, USA Paylean™ 9
To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.
Paylean, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.
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DIRECTIONS
BG230546X
Principal Display Panel – 25 Lbs Bag Label
Elanco™
AF0602
Paylean™9
(ractopamine hydrochloride
Type A medicated article)
For Use in Finishing Swine Feeds Only
Do not feed undiluted.
Net Weight 25 lbs
(11.34kg)
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.