Animal NDC 23243-7264-1 Optigrid 45
Ractopamine Hydrochloride
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 23243-7264-1 |
| Proprietary Name | Optigrid 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 | Huvepharma, Inc |
| Product Type | Otc Type A Medicated Article Animal Drug |
| Usage Information |
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| Active Ingredient(s) |
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| Inactive Ingredient(s) |
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| Marketing Category | ANADA - ABBREVIATED 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 | ANADA200679 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. |
Optigrid 45 Images
Optigrid 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
Huvepharma®
Optigrid® 45
(ractopamine hydrochloride Type A medicated article)
For use in Feeds For Cattle Fed in Confinement for Slaughter Only
Do Not Feed Undiluted
Net Weight 25 lb
(11.34 kg)
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
Indication: Complete Feed: For increased rate of weight gain, improved feed efficiency and increased carcass leanness in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.
Top Dress Feed: For increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.
Note: Carcass leanness effects are not an approved indication for use when feeding ractopamine by Top Dress Feeding methods.
Complete Feed
a Based on 90% Dry Matter Basis | ||
| Indications | Appropriate Concentration of Ractopamine in Type C Medicated Feed a | Ractopamine (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 The effect of ractopamine on parameters listed in this table is supported by data generated at the doses tested in the clinical field efficacy trials. | |||
NC = No Change, ↑ = Increased, ↓ = Decreased | |||
b Steers Only | |||
c Reduction indicates an improvement in USDA Yield Grade. | |||
| Carcass Measurements | Effect of Ractopamine a | ||
| 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 | ↑ | ↑ |
Top Dress Feed
a Based on 90% Dry Matter Basis | ||
| Indications | Appropriate Concentration of Ractopamine in Type C Medicated Feed a | Ractopamine (mg/hd/d) |
| Increased Rate of Weight Gain and Improved Feed Efficiency | Appropriate Concentration of Ractopamine in a minimum of 1.0 lb Top Dressed Type C Medicated Feeda (maximum of 800 g/ton) | 70-400 |
Inert Ingredients: Ground corn cobs.
Dosage & Administration
Mixing Directions (Complete Feed): Thoroughly mix Optigrid 45 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 (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 Concentration in Type B Medicated Feed b | |
| grams/ton | grams/pound | |
| 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 45 a Per Ton To Make a Type C Medicated Feed | Resulting Ractopamine 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 (Liquid Type B Feeds): Thoroughly mix Optigrid 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 (maximum 2300 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 Concentration in Liquid Type B Medicated Feed | |
| grams/ton | grams/pound | |
| 36.1 | 1,640 | 0.82 |
| 44.1 | 2,000 | 1.00 |
| 50.7 | 2,300 | 1.15 |
Mixing Directions for Preparing Type C Medicated Top Dress Feed: Thoroughly mix Optigrid 45 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 C Medicated Feed (maximum 800 g/ton).
The following table gives examples of how some Type C Medicated Top Dress 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 Type C Medicated Top Dress Feed | Resulting Ractopamine Concentration in Type C Top Dress Medicated Feed b | ||
| Top Dress | grams/ton | grams/pound | mg/pound |
| 2.20 | 100 | 0.05 | 50 |
| 4.41 | 200 | 0.10 | 100 |
| 6.61 | 300 | 0.15 | 150 |
| 8.81 | 400 | 0.20 | 200 |
| 17.62 | 800 | 0.40 | 400 |
Directions for Use (Complete Feed): Feed continuously to cattle fed in confinement for slaughter as the sole ration for the last 28 to 42 days on feed.
Directions for Use (Type C Medicated Top Dress Feed): Feed continuously to cattle fed in confinement for slaughter a Type C Medicated Feed containing up to a maximum of 800 g/ton ractopamine (see mixing direction table) to provide 70 to 400 mg/head/day for the last 28 to 42 days on feed. Type C Medicated Top Dress Feed must be fed in a minimum of 1.0 lb per head per day to provide 70 to 400 mg/head/day.
CAUTION: Not for animals intended for breeding.
NOT FOR HUMAN USE
Boxed Warning
WARNING: The active ingredient in Optigrid, ractopamine hydrochloride, is a beta-adrenergic agonist. Individuals with cardiovascular disease should exercise special caution to avoid exposure. Not for use in humans. Keep out of the reach of children. The Optigrid 45 formulation (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. The Safety Data Sheet contains more detailed occupational safety information. To report suspected adverse drug events, for technical assistance or to obtain
a copy of the SDS, contact Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.
Storage And Handling
Store at less than or equal to 25° C (77° F)
Excursions to 30°C (86° 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 ANADA # 200-679
TAKE TIME
OBSERVE LABEL DIRECTIONS
Optigrid® 45
Manufactured by:Huvepharma, Inc.
525 Westpark Dr., Ste 230
Peachtree City, GA 30269, U.S.A.
To report adverse effects, access medical information, or obtain additional product information, call 1-877-994-4883.
HUVEPHARMA and Optigrid 45 are trademarks of HUVEPHARMA EOOD.
Principal Display Panel – 25 Lb Bag Label
Huvepharma®
Optigrid® 45
(ractopamine hydrochloride Type A medicated article)
For use in Feeds For Cattle Fed in Confinement for Slaughter Only
Do Not Feed Undiluted
Net Weight 25 lb
(11.34 kg)
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.