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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
Active Ingredient(s)
  • Ractopamine Hydrochloride
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.

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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)

Do not feed undiluted.

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 4920 g/ton).

The following table gives examples of how some Type B Medicated Feed concentrations can be prepared:

Pounds of Paylean 45 To Add Per Ton To Make a Type B Medicated Feed

Resulting Ractopamine Concentration in Type B Medicated Feed

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 Ton of Type C Medicated Feed

Resulting Ractopamine
Concentration in Type C
Medicated Feed

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.


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
Medicated Feed

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 Ibs.

Variable

Last 45 lbs of body weight gain

Last 90 lbs of body weight gain

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



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.


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.

Paylean™ 45

TAKE TIME
OBSERVE LABEL
DIRECTIONS

Manufactured for:
Elanco US Inc
Greenfield, IN 46140, USA

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.

BG230547X


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.