Animal NDC 58198-0630-9 Optaflexx 45

Ractopamine Hydrochloride

Animal Product Information

Field Name	Field Value
Animal NDC Code	58198-0630-9
Proprietary Name	Optaflexx 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	Indications for Use: Complete Type C Medicated Feeds: For increased rate of weight gain, improved feed efficiency and increased carcass leanness in growing beef steers and heifers fed in confinement for slaughter during the last 28 to 42 days on feed. Not for use in cattle intended for breeding.Type C Top-Dress Medicated Feeds: For increased rate of weight gain and improved feed efficiency in growing beef steers and heifers fed in confinement for slaughter during the last 28 to 42 days on feed. Not for use in cattle intended for breeding. Note: Increased carcass leanness is not an approved indication for use with Top-Dress Feeding. Approved Concentrations of Ractopamine Hydrochloride in Complete Type C Medicated Feedsa Based on 90% Dry Matter Basis Indications for UseConcentration of Ractopamine Hydrochloride in Type C Medicated Feed aRactopamineHCl (mg/hd/d) Increased Rate of Weight Gain, and Improved Feed Efficiency 8.2 to 24.6 g/ton(9 ppm to 27 ppm) 70-430 Increased Rate of Weight Gain, Improved Feed Efficiency, and Increased Carcass Leanness 9.8 to 24.6 g/ton(11 ppm to 27 ppm) 90-430 a NC = No Change, ↑ = Increased, ↓ = Decreased b Steers Only c Reduction indicates an improvement in USDA Yield Grade. Carcass MeasurementsEffect of Ractopamine Hydrochloride a8.2 grams/ton(9 ppm) 16.4 grams/ton(18 ppm) 24.6 grams/ton(27 ppm) Hot Carcass Weight, lbs ↑ ↑ ↑ Dressing Percentage, % NC ↑b↑bCarcass Percent Fat, % NC ↓ ↓ 12th Rib Fat Thickness, in. NC NC NC Average Rib Eye Area, sq. in. ↑ ↑ ↑ USDA Yield Grade NC NC ↓cMarbling Score NC NC NC Rate of Carcass Lean Gain per Day NC ↑ ↑ Efficiency of Carcass Lean Gain per Day NC ↑ ↑ Approved Concentrations of Ractopamine Hydrochloride in Type C Top-Dress Medicated Feedsa Based on 90% Dry Matter BasisIndications for UseConcentration of Ractopamine HCl in Type C Top-Dress Medicated Feed aRactopamineHCl (mg/hd/d) Increased Rate of Weight Gain and Improved Feed Efficiency 100 to 800 g/ton in a minimum of 1 lb of Type C Top-Dress Medicated Feed70-400 Mixing Directions for Complete Type C Medicated Feeds: Thoroughly mix Optaflexx 45 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 4,920 g/ton). The following table gives examples of how some Type B Medicated Feed concentrations can be prepared: a Optaflexx 45 contains 45.4 g ractopamine hydrochloride per pound b Based on 90% Dry Matter Basis Pounds of Optaflexx 45 aTo Add Per Ton To Make aType B Medicated Feed Resulting Ractopamine HCl Concentration in Type B Medicated Feed bgrams/ton grams/pound 32.85000.2536.1 1,640 0.82 72.2 3,280 1.64 108.3 4,920 2.46 Thoroughly mix Optaflexx 45 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. 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 one ton of complete feed. a Optaflexx 45 contains 45.4 g ractopamine hydrochloride per pound b Based on 90% Dry Matter Basis Pounds of Optaflexx 45 a Per Ton To Make a Type C Medicated Feed Resulting Ractopamine HCl Concentration in Type C Medicated Feed b0.18 8.2 grams/ton (9 ppm) 0.36 16.4 grams/ton (18 ppm) 0.54 24.6 grams/ton (27 ppm) Mixing Directions for Type B Liquid Medicated Feeds: Thoroughly mix Optaflexx 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 2,300 g/ton). Maintain supplement pH at 4.5 to 7.5. For stored Type B Liquid Medicated Feeds containing ractopamine, recirculate immediately prior to use for not less than 10 minutes, moving not less than 1% of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not in use. The following table gives examples of how some Type B Liquid Medicated Feed concentrations can be prepared: a Optaflexx 45 contains 45.4 g ractopamine hydrochloride per pound Pounds of Optaflexx 45 aTo Add Per Ton To Make aType B Liquid Medicated Feed Resulting Ractopamine HCl Concentration in Type B Liquid Medicated Feedgrams/ton grams/pound 36.1 1,640 0.82 44.1 2,000 150.7 2,300 1.15 Mixing Directions for Type C Top-Dress Medicated Feeds: Thoroughly mix Optaflexx 45 Type A Medicated Article in a ton of appropriate feed ingredients according to the table below to obtain the proper concentration in the Type C Top-Dress Medicated Feed (100 to 800 g/ton). The following table gives examples of how some Type C Top-Dress Medicated Feed concentrations can be prepared: a Optaflexx 45 contains 45.4 g ractopamine hydrochloride per pound b Based on 90% Dry Matter Basis Pounds of Optaflexx 45 a To Add Per Ton To Make Type C Top-Dress Medicated FeedResulting Ractopamine HCl Concentration in Type C Top-Dress Medicated Feed bTop-Dressgrams/ton grams/pound mg/pound 2.2100 0.05 50 4.41 200 0.1100 6.61 300 0.15 150 8.81 400 0.2200 17.62 800 0.4400 Feeding Directions Complete Type C Medicated Feed: Feed as the sole ration during the last 28 to 42 days on feed.Type C Top-Dress Medicated Feed: Feed a minimum of 1 lb per head per day of Type C top-dress medicated feed containing 100 to 800 g/ton of ractopamine hydrochloride to provide 70 to 400 mg ractopamine hydrochloride per head per day during the last 28 to 42 days on feed.
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	NADA141221 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.

Optaflexx 45 Images

Optaflexx 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.

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Indications & Usage
Warnings
Storage And Handling
Principal Display Panel – 25 Lb Bag Label

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Elanco™

AF0630

Optaflexx™45

(ractopamine hydrochloride Type A medicated article)

For use in Feeds for Growing Beef Steers and Heifers Fed in Confinement for Slaughter Only

Net Weight 25 lb
(11.34 kg)

For further manufacturing only.

Active Drug Ingredient: Ractopamine Hydrochloride - 45.4 g per lb (100 g per kg)

Inert Ingredients: Ground corn cobs.

Important: Must be thoroughly mixed into feeds before use. Follow label directions.

Indications & Usage

Indications for Use: Complete Type C Medicated Feeds: For increased rate of weight gain, improved feed efficiency and increased carcass leanness in growing beef steers and heifers fed in confinement for slaughter during the last 28 to 42 days on feed. Not for use in cattle intended for breeding.

Type C Top-Dress Medicated Feeds: For increased rate of weight gain and improved feed efficiency in growing beef steers and heifers fed in confinement for slaughter during the last 28 to 42 days on feed. Not for use in cattle intended for breeding. Note: Increased carcass leanness is not an approved indication for use with Top-Dress Feeding.

Approved Concentrations of Ractopamine Hydrochloride in Complete Type C Medicated Feeds

^a Based on 90% Dry Matter Basis
Indications for Use	Concentration of Ractopamine Hydrochloride in Type C Medicated Feed ^a	Ractopamine HCl (mg/hd/d)
Increased Rate of Weight Gain, and Improved Feed Efficiency	8.2 to 24.6 g/ton (9 ppm to 27 ppm)	70-430
Increased Rate of Weight Gain, Improved Feed Efficiency, and Increased Carcass Leanness	9.8 to 24.6 g/ton (11 ppm to 27 ppm)	90-430

^a NC = No Change, ↑ = Increased, ↓ = Decreased
^b Steers Only
^c Reduction indicates an improvement in USDA Yield Grade.
Carcass Measurements	Effect of Ractopamine Hydrochloride ^a
Carcass Measurements	8.2 grams/ton (9 ppm)	16.4 grams/ton (18 ppm)	24.6 grams/ton (27 ppm)
Hot Carcass Weight, lbs	↑	↑	↑
Dressing Percentage, %	NC	↑^b	↑^b
Carcass Percent Fat, %	NC	↓	↓
12th Rib Fat Thickness, in.	NC	NC	NC
Average Rib Eye Area, sq. in.	↑	↑	↑
USDA Yield Grade	NC	NC	↓^c
Marbling Score	NC	NC	NC
Rate of Carcass Lean Gain per Day	NC	↑	↑
Efficiency of Carcass Lean Gain per Day	NC	↑	↑

Approved Concentrations of Ractopamine Hydrochloride in Type C Top-Dress Medicated Feeds

^a Based on 90% Dry Matter Basis
Indications for Use	Concentration of Ractopamine HCl in Type C Top-Dress Medicated Feed ^a	Ractopamine HCl (mg/hd/d)
Increased Rate of Weight Gain and Improved Feed Efficiency	100 to 800 g/ton in a minimum of 1 lb of Type C Top-Dress Medicated Feed	70-400

Mixing Directions for Complete Type C Medicated Feeds: Thoroughly mix Optaflexx 45 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 4,920 g/ton). The following table gives examples of how some Type B Medicated Feed concentrations can be prepared:

^a Optaflexx 45 contains 45.4 g ractopamine hydrochloride per pound
^b Based on 90% Dry Matter Basis
Pounds of Optaflexx 45 ^a To Add Per Ton To Make a Type B Medicated Feed	Resulting Ractopamine HCl Concentration in Type B Medicated Feed ^b
	grams/ton	grams/pound
32.8	500	0.25
36.1	1,640	0.82
72.2	3,280	1.64
108.3	4,920	2.46

Thoroughly mix Optaflexx 45 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. 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 one ton of complete feed.

^a Optaflexx 45 contains 45.4 g ractopamine hydrochloride per pound
^b Based on 90% Dry Matter Basis
Pounds of Optaflexx 45 ^a Per Ton To Make a Type C Medicated Feed	Resulting Ractopamine HCl Concentration in Type C Medicated Feed ^b
0.18	8.2 grams/ton (9 ppm)
0.36	16.4 grams/ton (18 ppm)
0.54	24.6 grams/ton (27 ppm)

Mixing Directions for Type B Liquid Medicated Feeds: Thoroughly mix Optaflexx 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 2,300 g/ton).

Maintain supplement pH at 4.5 to 7.5. For stored Type B Liquid Medicated Feeds containing ractopamine, recirculate immediately prior to use for not less than 10 minutes, moving not less than 1% of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not in use.

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

^a Optaflexx 45 contains 45.4 g ractopamine hydrochloride per pound
Pounds of Optaflexx 45 ^a To Add Per Ton To Make a Type B Liquid Medicated Feed	Resulting Ractopamine HCl Concentration in Type B Liquid Medicated Feed
	grams/ton	grams/pound
36.1	1,640	0.82
44.1	2,000	1
50.7	2,300	1.15

Mixing Directions for Type C Top-Dress Medicated Feeds: Thoroughly mix Optaflexx 45 Type A Medicated Article in a ton of appropriate feed ingredients according to the table below to obtain the proper concentration in the Type C Top-Dress Medicated Feed (100 to 800 g/ton).

The following table gives examples of how some Type C Top-Dress Medicated Feed concentrations can be prepared:

^a Optaflexx 45 contains 45.4 g ractopamine hydrochloride per pound
^b Based on 90% Dry Matter Basis
Pounds of Optaflexx 45 ^a To Add Per Ton To Make Type C Top-Dress Medicated Feed	Resulting Ractopamine HCl Concentration in Type C Top-Dress Medicated Feed^b
Top-Dress	grams/ton	grams/pound	mg/pound
2.2	100	0.05	50
4.41	200	0.1	100
6.61	300	0.15	150
8.81	400	0.2	200
17.62	800	0.4	400

Feeding Directions Complete Type C Medicated Feed: Feed as the sole ration during the last 28 to 42 days on feed.

Type C Top-Dress Medicated Feed: Feed a minimum of 1 lb per head per day of Type C top-dress medicated feed containing 100 to 800 g/ton of ractopamine hydrochloride to provide 70 to 400 mg ractopamine hydrochloride per head per day during the last 28 to 42 days on feed.

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 Optaflexx, ractopamine hydrochloride, is a beta-adrenergic agonist. Individuals with cardiovascular disease should exercise special caution to avoid exposure. The Optaflexx Type A medicated article poses a low dust potential under usual conditions of handling and mixing. When mixing and handling Optaflexx, 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: Behavioral signs such as agitation and decreased feed consumption have been reported in cattle fed ractopamine hydrochloride.

Additional Recommendations: See the Beef Quality Assurance (BQA) recommendations for best practices in cattle care and handling during Optaflexx feeding, transport, and marketing to help mitigate the behavioral signs stated in the Animal Safety Warnings section above.

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? To report side effects, access medical information, or obtain additional product information, 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 # 141-221

Optaflexx™ 45

Manufactured for: Elanco US, Inc

Indianapolis, IN 46221

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

Revision Date: NOV/2025

BG243489X
YL243489X

Lot
DOM
EXP

Principal Display Panel – 25 Lb Bag Label