RAVANTAGE 45- ractopamine hydrochloride powder

Ravantage 45 by

Drug Labeling and Warnings

Ravantage 45 by is a Animal medication manufactured, distributed, or labeled by Huvepharma, Inc, Huvepharma EOOD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Huvepharma®

Ravantage® 45

(ractopamine hydrochloride Type A medicated article)

For Use in Finishing Swine Feeds Only

Net Weight 25 lbs

(11.34 kg)

For further manufacturing only

ACTIVE INGREDIENT

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 & USAGE

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*
(5 to 10 ppm)
* No increased benefit has been shown when ractopamine hydrochloride
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.
Variable	Last 45 lbs of; body weight gain		Last 90 lbs of; body weight gain
	4.5 g/ton; ractopamine HCl	9.0 g/ton; ractopamine HCl	4.5 g/ton; ractopamine HCl	9.0 g/ton; ractopamine HCl
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	↑	↑	↑

Mixing Directions: Thoroughly mix Ravantage 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; Ravantage 45; To Add Per Ton To Make a; Type B Medicated Feed	Resulting Ractopamine HCl; 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 Ravantage 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 Ravantage 45 To Add Per Ton of Type C Medicated Feed:

  Resulting Ractopamine HCl ; Concentration ; in Type C Medicated Feed

• 0.10:

  4.5 grams/ton (5 ppm)

• 0.20:

  9 grams/ton (10 ppm)

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

Warnings

                           Withdrawal Periods:
            No withdrawal period is required when
                     used according to labeling.

USER SAFETY WARNINGS

User Safety Warnings: Not for use in humans. Keep out of reach of children.
The active ingredient in Ravantage, ractopamine hydrochloride, is a beta-adrenergic
agonist. Individuals with cardiovascular disease should exercise
special caution to avoid exposure. Ravantage Type A medicated article poses
a low dust potential under usual conditions of handling and mixing. When
mixing and handling Ravantage, 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 Huvepharma, Inc. at 1-877-994-4883.

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 Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.com.
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 ANADA # 200-768

Ravantage® 45

Manufactured for: Huvepharma, Inc.

525 Westpark Drive, Ste 230, Peachtree City, GA 30269, U.S.A.

HUVEPHARMA and Ravantage are trademarks owned or licensed by HUVEPHARMA EOOD, its subsidiaries or affiliates.
Made in Bulgaria.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RAVANTAGE 45 
ractopamine hydrochloride powder

Product Information
Product Type	OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC: 23243-5278
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ractopamine hydrochloride (UNII: 309G9J93TP) (ractopamine - UNII:57370OZ3P1)	ractopamine hydrochloride	45.4 g  in 0.45 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23243-5278-5	11.34 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200768	04/01/2025

Labeler - Huvepharma, Inc (619153559)