Animal NDC 58198-0610-9 Paylean 45
Ractopamine Hydrochloride
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 58198-0610-9 |
| Proprietary Name | Paylean 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 | Elanco Us Inc. |
| Product Type | Otc Type A Medicated Article Animal Drug |
| Usage Information |
|
| Active Ingredient(s) |
|
| 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 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
Elanco™
AF0610
Paylean™ 45
(ractopamine hydrochloride Type A medicated article)
For Use in Finishing Swine Feeds Only
Net Weight 25 lb
(11.34 Kg)
For further manufacturing only.
Mixing Directions: Thoroughly mix Paylean 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 4,920 g/ton).
The following table gives examples of how some Type B Medicated Feed concentrations can be prepared:
Pounds of Paylean 45 To Add | Resulting Ractopamine HCl | |
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 Paylean 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 Paylean 45 To Add Per | Resulting Ractopamine HCl |
0.10 | 4.5 grams/ton (5 ppm) |
0.20 | 9 grams/ton (10 ppm) |
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 For Use:
For increased rate of weight gain, improved feed efficiency and increased carcass leanness in finishing swine, weighing at least 150 lbs, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lbs of gain prior to slaughter. Not for use in swine intended for breeding.
Approved Concentrations of Ractopamine Hydrochloride in Type C Medicated Feed |
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 as the sole ration to finishing swine weighing at least 150 lbs for the last 45 to 90 lbs (group average) of weight gain prior to slaughter.
Warnings
Withdrawal Periods:
No withdrawal period is required when
used according to labeling.
User Safety Warnings: Not for use in humans. Keep out of reach of children. The active ingredient in Paylean, ractopamine hydrochloride, is a beta-adrenergic agonist. Individuals with cardiovascular disease should exercise special caution to avoid exposure. Paylean Type A medicated article poses a low dust potential under usual conditions of handling and mixing. When mixing and handling Paylean, 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. To obtain a Safety Data Sheet(s), contact Elanco US Inc. at 1-800-428-4441.
Animal Safety Warnings: Ractopamine hydrochloride use may increase the number of injured, lame, and/or fatigued pigs during marketing. Behavioral signs such as hyperactivity, anxiety, and aggression have been reported in pigs fed ractopamine hydrochloride.
Additional Recommendations: To help mitigate the signs identified in the Animal Safety Warnings section, see the Pork Quality Assurance (PQA Plus) and Transport Quality Assurance (TQA) recommendations for best practices in swine care during handling, transport, and marketing.
Storage And Handling
Storage and Handling: 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.
Questions/Comments?: For technical assistance or to report side effects, contact Elanco US Inc. at 1-800-428-4441.
For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.
Restricted Drug (California) -
Use Only as Directed
Approved by FDA under NADA # 140-863
Paylean™ 45
Manufactured for:
Elanco US Inc.
Indianapolis, IN 46221
Paylean, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.
© 2025 Elanco or its affiliates
Revision Date: September 2025
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Lot
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Principal Display Panel - Paylean 45 Bag Label
Elanco™
AF0610
Paylean™ 45
™
(ractopamine hydrochloride
Type A medicated article)
For Use in Finishing Swine Feeds Only
Net Weight 25 lb
(11.34 Kg)
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.
