Animal NDC 86101-020-13 Praziquantel

Animal Product Information

Field Name Field Value
Animal NDC Code 86101-020-13
Proprietary Name Praziquantel 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 Praziquantel 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 Felix Pharmaceuticals Private Limited
Product Type Prescription Animal Drug
Usage Information
    Praziquantel Tablets 23 mg Feline Cestocide are indicated for the removal of the following canine cestodes: Dipylidium caninum and Taenia,taeniaeformis.  
Active Ingredient(s)
  • Praziquantel
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 ANADA200834 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.

Praziquantel 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



CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Each Chewable Tablet contains 23 mg praziquantel.


Description



Praziquantel Tablets 23 mg Feline Cestocide are sized for easy oral administration to either adult cats or kittens. The tablets may be crumbled and mixed with the feed.




Indications



Praziquantel Tablets 23 mg Feline Cestocide are indicated for the removal of the following canine cestodes: Dipylidium caninum and Taenia,taeniaeformis.



 


Contraindications



There are no known contraindications to the use of praziquantel in cats.


Action



Praziquantel Tablets are absorbed, metabolized in the liver and excreted in the bile. Upon entering the digestive tract from the bile, cestocidal activity is exhibited.1

Following exposure to praziquantel, the tapeworm loses its ability to resist digestion by the mammalian host. Because of this, whole tapeworms, including the scolex, are very rarely passed after administration of praziquantel. In many instances only disintegrated and partially digested pieces of tapeworms will be seen in the stool. The majority of tapeworms killed are digested and are not found in the feces.




Use Directions



Praziquantel Tablets 23 mg Feline Cestocide may be administered directly per os or crumbled and mixed with the feed. The recommended dosage of praziquantel varies according to body weight. Smaller animals require a relatively larger dosage because of their higher metabolic rate. The optimum dose for each individual animal will be achieved by utilizing the following dosage schedule:


Cats and Kittens*
 4 pound and under ½ tablet
 5-11 pounds. 1 tablet
Over 11 pounds 1½ tablets

*Not intended for use in kittens less than 6 weeks of age.


Fasting



The recommended dosage of praziquantel is not affected by the presence or absence of food in the gastrointestinal tract, therefore, FASTING IS NEITHER NECESSARY NOR RECOMMENDED.


Retreatment



For those animals maintained on premises where reinfections are likely to occur, clients should be instructed in the steps necessary to prevent reinfection; otherwise, retreatment may be necessary. This is especially true in cases of Dipylidium caninum infections where reinfection is almost certain to occur if fleas are not removed from the animal and its environment.



Animal Safety



The safety index has been derived from controlled safety evaluations, clinical trials and prior approved use in foreign countries.

Dosages of 5 times the labeled rate at 14 day intervals to cats as young as 5½ weeks did not produce clinical signs of toxicity. No significant clinical chemistry, hematological, or histopathological changes occurred. Symptoms of gross overdosage include vomition, salivation, diarrhea and depression.


Pregnancy



Praziquantel tablets have been tested in breeding and pregnant dogs. No adverse effects were noted.


Adverse Reactions



One instance of diarrhea and one of salivation (1.5%) were reported during the field trials in which 135 cats were administered praziquantel tablets 23 feline cestocide.


Contact Information



Contact Felix Pharmaceuticals Private Limited at 1-833-571-1525. To report suspected adverse drug experiences, contact Felix Pharmaceuticals Private
Limited at 1-833-571-1525. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae
To obtain a Safety Data Sheet(s), contact Felix Pharmaceuticals Private Limited at 1-833-571-1525.


Warning



Keep out of the reach of children. Not for human use.


Storage



Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].


How Supplied



Bottle of 3, 50 and 150 scored tablets.

Each scored tablet contains 23 mg praziquantel.



NDC Number 

Tablet Size

Tablets/Bottle

 86101-020-21

23 mg 

3 Tablets 

 86101-020-50

23 mg

50 Tablets

 86101-020-13

23 mg

150 Tablets 


References



1Andrews, P. Pharmacokinetic Studies with Droncit® in Animals Using a Biological Assay. Veterinary Medical Review 2/76: 154-165.

Approved by FDA under ANADA # 200-834


Distributed by:
Felixvet Inc.,
1300 NW Briarcliff Parkway,
Suite 100, Kansas City, Missouri 64150


Made in India


Neutral Code No. MP/DRUGS/25/90/2020


Rev. November 2025 


Package Label.Principal Display Panel



NDC 86101-020-21

Praziquantel Tablets

23 mg

Feline Cestocide

CAUTION: Federal (U.S.A) law restricts this drug to use by or on the order of a licensed veterinarian.

WARNING: KEEP OUT OF REACH OF CHILDREN. NOT FOR HUMAN USE.

EACH TABLET CONTAINS: 23 mg praziquantel

3 Chewable Tablets

Approved by FDA under ANADA # 200-834

NDC 86101-020-50

Praziquantel Tablets

23 mg

Feline Cestocide

CAUTION: Federal (U.S.A) law restricts this drug to use by or on the order of a licensed veterinarian.

WARNING: KEEP OUT OF REACH OF CHILDREN. NOT FOR HUMAN USE.

EACH TABLET CONTAINS: 23 mg praziquantel

50 Chewable Tablets

Approved by FDA under ANADA # 200-834

NDC 86101-020-13

Praziquantel Tablets

23 mg

Feline Cestocide

CAUTION: Federal (U.S.A) law restricts this drug to use by or on the order of a licensed veterinarian.

WARNING: KEEP OUT OF REACH OF CHILDREN. NOT FOR HUMAN USE.

EACH TABLET CONTAINS: 23 mg praziquantel

150 Chewable Tablets

Approved by FDA under ANADA # 200-834

  



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