Animal NDC 57926-475-62 Chorulon

Gonadotrophin, Chorionic

Animal Product Information

Field Name Field Value
Animal NDC Code 57926-475-62
Proprietary Name Chorulon 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 Gonadotrophin, Chorionic 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 Merck Sharp & Dohme Corp.
Product Type Prescription Animal Drug
Usage Information
    INDICATIONS
Active Ingredient(s)
  • Human Chorionic Gonadotropin
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • WATER (059QF0KO0R)
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 NADA140927 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.

Chorulon 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



(chorionic gonadotropin for injection)

Approved by FDA under NADA # 140-927

FOR ANIMAL USE ONLY

COWS: CHORULON® is indicated for intramuscular use in cows for the treatment of nymphomania (frequent or constant heat) due to cystic ovaries.

FINFISH: CHORULON® is indicated for use as an aid in improving spawning function in male and female brood finfish.

COWS: The contents of one vial (10 mL) of reconstituted CHORULON® should be administered as a single deep intramuscular injection. Dosage may be repeated in 14 days if the animal's behavior or rectal examination of the ovaries indicates the necessity for retreatment.

FINFISH: CHORULON® should be administered via intramuscular injection just ventral to the dorsal fin for one (1) to three (3) injections. Any single injection should be administered, depending on the fish species, at a dose of 50 to 510 IU/lb body weight (bw) for males and 67 to 1816 IU/lb bw for females. Depending on body weight and dose administered, it may be necessary to divide the dose among two or more injection sites to avoid injecting a large volume at a single site.

Summaries of doses tested in representative fish species are contained within the following tables. The dose of CHORULON® to be used in other species of finfish may differ from those species listed in the tables, but should fall within the suggested range of 50 to 510 IU/lb bw for males and 67 to 1816 IU/lb bw for females.

Table 1: Tested Fish Species/Dose Combinations Found to be Effective
Nomenclature Common Name, Genus & Species, FamilyTested Dose(s)
(IU/lb bw/injection)
Number of InjectionsInjections Interval (h)
MalesFemales
Footnotes:
yellow perch, Perca flavescens, Percidaent167-3001-
striped bass, Morone saxitilis, Percichthyidae50-50075-2521-
white bass, Morone chrysops, Percichthyidae65-51091-7501-
razorback sucker, Xyrauchen texanus, Catostomidaent

nt = not tested

100324
walleye, Stizostedion vitreum, Percidae75-400145-8301-372
red snapper, Lutjanus campechanus, Lutjanidae2505001-
sauger, Stizostedion canadense, Percidae500500-10001-
Chinese catfish, Clarius fuscus, Clariidaent18161-
Table 2: Tested Fish Species/Dose Combinations Found to be Safe
Nomenclature Common Name, Genus & Species, FamilyTested Dose(s)
(IU/lb bw/injection)
Number of InjectionsInjections Interval (h)
MalesFemales
white bass, Morone chrysops, Percichthyidae75015001-
walleye, Stizostedion vitreum, Percidae75015001-
grass carp, Ctenopharyngodon idella, Cyprinidae250050001-
channel catfish, Ictalurus punctatus, Ictaluridae250050001-

Distributed by Intervet Inc. (d/b/a Merck Animal Health), Rahway, NJ 07065.

Copyright © 2025 Merck & Co., Inc., Rahway, NJ, USA and its affiliates.

All rights reserved.

Made in Germany.

Rev. 10/2025

232977 R3 INU 240
05


Precautions



CAUTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.


Description



DESCRIPTION

CHORULON® is a freeze-dried preparation of chorionic gonadotropin (human Chorionic Gonadotropin or hCG) for intramuscular administration after reconstitution. When reconstituted with the accompanying sterile diluent, each 10 mL vial contains 10,000 IU chorionic gonadotropin (equivalent to 10,000 USP Units chorionic gonadotropin) and 10 mg mannitol, with mono- and disodium phosphate to adjust the pH of the solution.


Mechanism Of Action



ACTION

Chorionic gonadotropin has luteinizing hormone-like activity with little or no follicle stimulating or estrogenic activity. Product does not conform to the USP monograph for estrogenic activity. Demonstration of the lack of estrogenic activity is performed at the drug substance level.


Indications & Usage



INDICATIONS


Dosage & Administration



DOSAGE AND ADMINISTRATION

To reconstitute, transfer the contents of one vial of sterile diluent into one vial of freeze-dried powder. The resulting 10 mL of CHORULON® contains 10,000 IU chorionic gonadotropin.


Adverse Reactions



ADVERSE REACTIONS

Chorionic gonadotropin is a protein. In the unlikely event of an anaphylactic reaction, epinephrine should be administered. The administration of an antihistamine may also be indicated.


Residue Warning



RESIDUE WARNINGS

No withdrawal period is required for cows or brood finfish treated according to label directions. The total dose administered (all injections combined) should not exceed 25,000 IU (25 mL) per fish in fish intended for human consumption.


Storage And Handling



STORAGE AND HANDLING PRECAUTIONS

Store at or below room temperature, 25°C (77°F). Keep out of reach of children. Once reconstituted, CHORULON® should be used immediately. Unused solution should be disposed of properly and not stored for future use.


How Supplied



HOW SUPPLIED

CHORULON® is supplied in cartons containing five vials of freeze-dried powder and five 10 mL vials of sterile diluent.


Principal Display Panel - 5 Vials Kit Carton



5 vials with diluent

chorulon®
(chorionic gonadotropin for injection)

MERCK
Animal Health


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