Animal NDC 51233-101-50 Ovugel

Triptorelin Acetate

Animal Product Information

Field Name Field Value
Animal NDC Code 51233-101-50
Proprietary Name Ovugel 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 Triptorelin 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 United-ah Ii, Llc
Product Type Otc Animal Drug
Usage Information
    For the synchronization of time of insemination in weaned sows to facilitate a single fixed-time artificial insemination.  Not approved for use in gilts.  Safety and effectiveness have not been evaluated in these animals.
Active Ingredient(s)
  • Triptorelin Acetate
Marketing Category NADA - 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 NADA141339 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.

Ovugel 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



Active Ingredient:



triptorelin acetate


Dosage Form & Strength:



100 mcg triptorelin per mL (as triptorelin acetate)
Gel for intravaginal use


Indications For Use:



For the synchronization of time of insemination in weaned sows to facilitate a single fixed-time artificial insemination.  Not approved for use in gilts.  Safety and effectiveness have not been evaluated in these animals.


Description:



OvuGel is a thin, clear to slightly hazy gel.  Each mL of OvuGel contains 100 mcg of triptorelin (as triptorelin acetate) for intravaginal administration.


Warnings:



WITHDRAWAL PERIOD:
No withdrawal period is required when used according to labeling.

USER SAFETY WARNINGS:
Not for Use in Humans.  Keep Out of Reach of Children.  The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information.

ANIMAL SAFETY WARNINGS:
OvuGel should not be used in sows with obvious reproductive tract abnormalities.


Recommendations For Safe And Effective Use:



Use of a bottle mount multi-dose applicator is recommended to ensure accurate dosing.
The use of adequate sperm numbers per insemination and proper semen storage, as recommended by the semen or artificial inseminator catheter suppliers, is recommended.


Directions For Use:



OvuGel should be administered intravaginally at approximately 96 hours after weaning.  The product should be warmed at room temperature for a minimum of 10 minutes prior to use.  Insert the delivery tube into the vagina so that the tip rests 1/2 inch (1-3 cm) posterior to the cervix.  Use a separate sheath over the delivery tube for each sow treated.  Each sow should receive a single 2 mL dose of OvuGel.  Sows should be inseminated 22 +/- 2 hours following administration of OvuGel using standard artificial insemination techniques.  Sows should be exposed to a boar during time of insemination.  (See end of package insert for more detailed directions for OvuGel administration).


Storage, Handling, And Disposal:



Store at refrigerator temperature 36-46°F (2-8°C).  Excursions permitted to 77°F (25°C) for no more than 5 days during shipping.
OvuGel should be administered within 1 hour of warming; unused portions may be refrigerated immediately after use.  The bottle stopper may be punctured a maximum of three times.  Discard 28 days after the stopper is first punctured.


How Supplied:



OvuGel is available in 52.5 mL multi-dose bottle (carton of 6).


Questions/Comments:



To obtain an MSDS, for technical assistance, or to report adverse events, contact United-AH II, LLC at 888-842-7218 or www.ovugel.com.  For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS, or www.fda.gov/reportanimalae.


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.