OPTIGRID 45- ractopamine hydrochloride powder

Optigrid 45 by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Huvepharma®

Optigrid® 45

(ractopamine hydrochloride Type A medicated article)

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

For further manufacturing only

Net Weight 25 lb
(11.34 kg)

ACTIVE INGREDIENT

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 Feeda	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 Hydrochloridea
	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 Feeda	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 Feeda	70-400

INDICATIONS & USAGE

Mixing Directions for Complete Type C Medicated Feeds: Thoroughly mix Optigrid 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 Optigrid 45 contains 45.4 g ractopamine hydrochloride per pound
b Based on 90% Dry Matter Basis
Pounds of Optigrid 45 a; To Add Per Ton To Make a; Type B Medicated Feed	Resulting Ractopamine HCl Concentration in; Type B Medicated Feedb
	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 Optigrid 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 Optigrid 45 contains 45.4 g ractopamine hydrochloride per pound
b Based on 90% Dry Matter Basis
Pounds of Optigrid 45a Per Ton To Make; a Type C Medicated Feed	Resulting Ractopamine HCl Concentration in; Type C Medicated Feedb
0.18	8.2 grams/ton (9 ppm)
0.36	16.4 grams/ton (18 ppm)
0.54	24.6 grams/ton (27 ppm)

INDICATIONS & USAGE

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

Maintain supplement pH at 4.5 to 7.5. For stored liquid Type B 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 Medicated Feed concentrations can be prepared:

a Optigrid 45 contains 45.4 g ractopamine hydrochloride per pound
Pounds of Optigrid 45 a To Add Per Ton To Make a; Liquid Type B 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

INDICATIONS & USAGE

Mixing Directions for Type C Top-Dress Medicated Feeds: Thoroughly mix Optigrid 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:

aOptigrid 45 contains 45.4 g ractopamine hydrochloride per pound
bBased on 90% Dry Matter Basis
Pounds of Optigrid 45a To Add Per Ton To; Make Type C Top-Dress Medicated Feed	Resulting Ractopamine HCl Concentration; in Type C Top-Dress Medicated Feedb
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

DOSAGE & ADMINISTRATION

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

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 Optigrid, ractopamine hydrochloride,
is a beta-adrenergic agonist. Individuals with cardiovascular disease should exercise special caution to avoid exposure. The Optigrid
Type A medicated article poses a low dust potential under usual conditions of handling and mixing. When mixing and handling Optigrid, 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: 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
Optigrid 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? 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 # 200-679

Optigrid® 45

Manufactured for:  Huvepharma, Inc.
                               525 Westpark Dr., Ste 230
                               Peachtree City, GA 30269, U.S.A.

HUVEPHARMA and Optigrid 45 are trademarks of HUVEPHARMA EOOD.
Made in Bulgaria

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OPTIGRID 45 
ractopamine hydrochloride powder

Product Information
Product Type	OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC: 23243-7264
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

Inactive Ingredients
Ingredient Name	Strength
POVIDONE (UNII: FZ989GH94E)
CASTOR OIL (UNII: D5340Y2I9G)
CORN COB (UNII: XXP8V4H4NY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23243-7264-1	11.34 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200679	01/21/2021

Labeler - Huvepharma, Inc (619153559)