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 |
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| Active 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 | 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 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)
Heifers Fed in Confinement for Slaughter:
For Increased Rate of Weight Gain, Improved Feed Efficiency and Suppression of Estrus (Heat).
Heifers Intended for Breeding: For Suppression of Estrus (Heat).
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%
Precautions
PRECAUTIONS: For manufacturing, processing, or repacking. To be mixed with feed prior to animal use.
Use only as directed. Excessive contact with skin should be avoided. Destroy empty container. Do not reuse.
Storage And Handling
Store at 4° - 25°C (39° - 77°F).
Excursions permitted up to 40°C (104°F).
Approved by FDA under ANADA #200-399
Net Weight 40 Pounds (18 kg)
(4.627gal [17.5 L])
HUVEPHARMA®
KCP-S00037
Version 02 Rev. 02-2022
Indications & Usage
DIRECTIONS FOR USE:
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 2.0 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 0.50 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.
Heifers Intended for Breeding:
CycleGuard 500 should be thoroughly mixed in the supplement to provide 0.5 mg of melengestrol
acetate per head per day.
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.
Heifers Intended for Breeding:
Do not exceed 24 days of feeding of melengestrol acetate to heifers intended for
breeding. 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.
Warnings And Precautions
WARNINGS: Not for human use. Restricted Drug (California)—Use Only As Directed
PRECAUTIONS: Not effective in steers and spayed heifers.
Dosage & Administration
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 1992 to 1980 lbs of non-medicated
feed. Labeling for such Type B feed shall contain directions for manufacturing
Type C medicated feeds containing 0.25 to 2.0 grams melengestrol acetate per ton
(0.125 to 1.0 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 2.0 pounds per head per day. Good manufacturing practice regulations
must be adhered to in manufacturing feeds containing CycleGuard 500.
Adverse Reactions
To report suspected adverse drug events, for technical assistance or to obtain a copy
of the Safety Data Sheet (SDS), contact Huvepharma, Inc. at 1-877-994-4883 or
www.huvepharma.us. For additional information about adverse drug experience reporting
for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.
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* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.