Animal NDC 58198-5567-1 Experior 50

Lubabegron

Animal Product Information

Field Name Field Value
Animal NDC Code 58198-5567-1
Proprietary Name Experior 50 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 Lubabegron 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 Animal Drug
Usage Information
    For reduction of ammonia gas emissions per pound of live weight and hot carcass weight in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed.Effectiveness has not been demonstrated when fed for less than 14 days.Ammonia gas emissions were measured for individual animals or small groups of animals held in environmentally controlled facilities. Based on existing information, reliable predictions of the reduction of ammonia gas emissions cannot be made on a herd, farm, or larger scale.Increased rate of weight gain, improved feed efficiency, and increased carcass leanness have not been demonstrated with this product.
Active Ingredient(s)
  • Lubabegron
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 NADA141508 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.

Experior 50 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



Experior™50Tm



(lubabegron Type A medicated article)

For Use in Feeds for Beef Steers and Heifers Fed in Confinement for Slaughter


Important:



For further manufacturing only. Experior 50 must be thoroughly mixed into feeds before use. Follow label directions.


Active Drug Ingredient:



Lubabegron (as lubabegron fumarate) - 50 g per kg (22.7 g per lb)


Inert Ingredients:



Corn cob grits, mineral oil, citric acid.


Indications For Use:



For reduction of ammonia gas emissions per pound of live weight and hot carcass weight in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed.

Effectiveness has not been demonstrated when fed for less than 14 days.

Ammonia gas emissions were measured for individual animals or small groups of animals held in environmentally controlled facilities. Based on existing information, reliable predictions of the reduction of ammonia gas emissions cannot be made on a herd, farm, or larger scale.

Increased rate of weight gain, improved feed efficiency, and increased carcass leanness have not been demonstrated with this product.


Mixing Directions (Dry Type B Medicated Feeds):



Thoroughly mix Experior 50 Type A medicated article in a ton of appropriate feed ingredients according to the table below to obtain the proper concentration in the Type B medicated feed (maximum 720 g/ton). If mixing less than 5 pounds of Type A medicated article per ton to make a dry Type B medicated feed, you must prepare an intermediate pre-blend by thoroughly mixing the required amount of Experior 50 Type A medicated article in a convenient quantity of feed ingredients, and then add the pre-blend into the remaining feed ingredients to make a dry Type B medicated feed. The following table gives examples of how some Type B medicated feed concentrations can be prepared:

a Experior 50 contains 22.7 grams of lubabegron per pound
b Based on 90% Dry Matter Basis

Pounds of Experior 50 Type Aa
To Add Per Ton To Make
a Type B Medicated Feed

Resulting lubabegron Concentration in
Type B Medicated Feedb

grams/ton

2.0

45.4

15.4

350

31.7

720


Mixing Directions (Liquid Type B Medicated Feeds):



Thoroughly mix Experior 50 Type A medicated article in a ton of appropriate feed ingredients or diluents according to the table below to obtain the proper concentration in the Type B Medicated Feed (15.5 to 185 g/ton). If mixing less than 5 pounds of Type A medicated article per ton to make a Type B liquid medicated feed, you must prepare an intermediate pre-blend by thoroughly mixing the required amount of Experior 50 Type A medicated article in a convenient quantity of feed ingredients or diluents, and then mix the pre-blend into the remaining feed ingredients or diluents to make a Type B liquid medicated feed.

Formulate medicated feed to a pH of 4 to 9 and dry matter content of 60% to 75%. Liquid Type B Medicated Feeds containing Experior stored in recirculation tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving no less than 1% of the tank contents per minute from the bottom to the top of the tank. Recirculate daily as described even when not used. For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.

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

a Experior 50 contains 22.7 g lubabegron per pound

Pounds of Experior 50 Type Aa
To Add Per Ton to Make a
Liquid Type B Medicated Feed

Resulting lubabegron Concentration in
Liquid Type B Medicated Feed

grams/ton

0.7

15.5

4.4

100

8.1

184


Mixing Directions (Dry Type C Medicated Complete Feeds):



Thoroughly mix Experior 50 Type A medicated article in a ton of complete cattle feed according to the table below to obtain the proper concentration in the Type C medicated feed. You must prepare an intermediate pre-blend by thoroughly mixing the required amount of Experior 50 Type A medicated article in a convenient quantity of feed ingredients, and then add the pre-blend to the remaining feed ingredients to make a complete feed.

a Experior 50 contains 22.7 grams of lubabegron per pound
b Based on 90% Dry Matter Basis
c Value is rounded. Rounded value from 0.0551.

Pounds of Experior 50 Type Aa
To Add Per Ton To Make a Type C Medicated Feed

Resulting lubabegron Concentration (g/ton)
in Type C Medicated Feedb

0.06c

1.25

0.11

2.50

0.20

4.54


Feeding Directions:



Feed 1.25 to 4.54 g/ton (1.39 to 5 ppm) of complete feed (90% dry matter basis) to provide 13-90 mg lubabegron/head/day continuously to beef steers and heifers fed in confinement for slaughter as the sole ration during the last 14 to 91 days on feed.


Caution:



Not approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Do not allow horses or other equines access to feed containing Experior 50. A decrease in dry matter intake may be noticed in some animals.


Warnings:



No withdrawal period is required when used according to labeling.


User Safety Warning:



The active ingredient in Experior 50, lubabegron, is a beta-adrenergic agonist/antagonist. Individuals with cardiovascular disease should exercise special caution to avoid exposure. Not for human use. Keep out of reach of children. When mixing and handling Experior 50, 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 thoroughly with water; if wearing contact lenses, rinse eyes first, then remove contact lenses and continue to rinse for 5-20 minutes. If irritation persists, seek medical attention. The safety data sheet contains more detailed occupational safety information. To report adverse drug events, access medical information, or obtain additional product information, call Elanco US Inc. at 1-800-428-4441. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

Lot No:

Expiry Date:


Storage Information:



Store at or below 25°C (77°F). Excursions permitted to 30°C (86°F).

Not to be used after the date printed on the bag.

Restricted Drug (California) – Use Only as Directed

Approved by FDA under NADA #141-508

Manufactured For:

Elanco US Inc.

2500 Innovation Way

Greenfield, IN 46140, U.S.A.

Experior, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

© 2021 Elanco or its affiliates

Net Weight 10 kg
(22.04 lb)

TAKE TIME

OBSERVE LABEL
DIRECTIONS

YL103064X


Principal Display Panel - 50 Kg Bag Label



Elanco

Experior50

(lubabegron Type A
medicated article)


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.