Animal NDC 23243-0068-1 Cycleguard 500
Melengestrol Acetate
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 23243-0068-1 |
| Proprietary Name | Cycleguard 500 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 | Melengestrol Acetate 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 |
|
| Active Ingredient(s) |
|
| 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 | ANADA200399 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. |
Cycleguard 500 Images
Cycleguard 500 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
CycleGuard® 500
(melengestrol acetate Type A liquid medicated article)
Indications for Use:
For increased rate of weight gain, improved feed effciency, and suppression of estrus
(heat) in growing beef heifers fed in confnement for slaughter.
For suppression of estrus (heat) in replacement beef and dairy heifers.
Each Pound Contains:
Active Drug Ingredient:
Melengestrol Acetate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 500 mg
(as melengestrol acetate and its propylene glycol ketal)
Inactive Ingredient:
Propylene Glycol, U.S.P. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99.89%
For further manufacturing only.
Approved by FDA under ANADA #200-399
Manufactured For: Huvepharma, Inc.
525 Westpark Dr. Suite 230
Peachtree City, GA 30269
1-877-994-4883
Restricted Drug (California)—Use Only As Directed
Storage And Handling
Storage and Handling: Store at 4° - 25°C (39° - 77°F). Excursions permitted up to 40°C (104°F).
Destroy empty container. Do not reuse.
Adverse Reactions
Question/Comments? For technical assistance or to obtain a Safety Data Sheet(s), contact
Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.us. To report side effects, contact
Huvepharma, Inc. at 1-877-994-4883. For additional information about reporting side effects,
contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae
Approved by FDA under ANADA # 200-399
Net Weight 40 Pounds (18 kg) (4.627gal [17.5 L])
Indications & Usage
DIRECTIONS FOR USE:
Growing beef heifers fed in confinement for slaughter:
CycleGuard® 500 (melengestrol acetate Type A liquid medicated article) should be thoroughly mixed in liquid Type C medicated
feed which must be fed at 0.5 to 2 pounds per head daily to provide 0.25 to 0.5 mg of melengestrol acetate per head per day.
Average daily intakes approximating the middle of this range provide the most optimal and economical improvements in rate of gain
and feed utilization. Constant daily intakes of 0.35 to 0.5 mg per head per day give a high degree of estrus suppression. Levels of
0.25 to 0.35 mg provide a lower but still effective degree of estrus suppression.
Replacement beef and dairy heifers:
CycleGuard 500 should be thoroughly mixed in the supplement to provide 0.5 mg of melengestrol acetate per head per day.
ADDITIONAL RECOMMENDATIONS:
Not effective in steers and spayed heifers.
Growing beef heifers fed in confinement for slaughter:
Withdrawal periods of three to five days or more should be avoided to prevent the possibility that the heifers may come into estrus
(heat) at loading time.
Replacement beef and dairy heifers:
Do not exceed 24 days of feeding of melengestrol acetate. A reduced conception rate can be expected if heifers are bred at
estruses observed within 1 to 12 days after withdrawal of melengestrol acetate, whereas heifers bred at subsequent observed
estruses are expected to have normal conception rates.
Dosage & Administration
MIXING DIRECTIONS:
Liquid Type B and C medicated feeds containing melengestrol acetate must have a pH of 4 to 8 and their labels must bear
appropriate mixing directions. Mixing directions for liquid Type B or C feeds stored in recirculation tank systems are: “Recirculate
immediately prior to use for no less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the
bottom of the tank to the top. Recirculate daily, as directed in this paragraph even when the Type B (or C) feed is not used.” Mixing
directions for liquid Type B and C feeds stored in mechanical, air or other agitation-type tank systems are: “Agitate immediately
prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily, as
directed in this paragraph, even when the Type B (or C) feed is not used.”
Intermediate medicated feeds should not be made from CycleGuard 500 except as a part of a continuous mixing operation to make
a complete liquid Type B or Type C medicated feed.
Thoroughly mix 0.5 to 4 pounds of CycleGuard 500 per ton of a non-medicated feed to prepare a Type C medicated feed containing
0.25 to 2 grams of melengestrol acetate per ton. The following Table may be used as a guide in determining the amount of
CycleGuard 500 to be added to prepare a ton of Type C medicated feed.
Type B medicated feed containing 4 to 10 grams melengestrol acetate per ton may be manufactured by thoroughly mixing 8 to 20 lbs of
CycleGuard® 500 (melengestrol acetate Type A liquid medicated article) with 1,992 to 1,980 lbs of non-medicated feed. Labeling for such Type B
feed shall contain directions for manufacturing Type C medicated feeds containing 0.25 to 2 grams melengestrol acetate per ton (0.125 to 1
mg/lb). The Type C medicated feed, containing melengestrol acetate, must be top dressed on grain or roughage or mixed with a complete ration
at the rate of 0.5 to 2 pounds per head per day.
Good manufacturing practice regulations must be adhered to in manufacturing feeds containing CycleGuard 500.
Residue Warning
WITHDRAWAL PERIOD:
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.
Package Label.Principal Display Panel
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