Sarolaner, Moxidectin, And Pyrantel Tablet, Chewable
NDC Package 54771-2684-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Sarolaner, Moxidectin, And Pyrantel tablets is sIMPARICA TRIO is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina) and hookworm (L4, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala) infections. This formulation utilizes a tablet, chewable delivery system. Marketed by Zoetis Inc., this product is identified by NDC 54771-2684.

Identification & Billing

NDC Package Code
54771-2684-0
Package Description
30 TABLET, CHEWABLE in 1 DRUM
Product Code
54771-2684
11-Digit Billing Format
54771268400
RxNorm Crosswalk
  • RxCUI: 2281736 - moxidectin 0.24 MG / pyrantel pamoate 50 MG / sarolaner 12 MG Chewable Tablet
  • RxCUI: 2281743 - Simparica TRIO 0.24 MG / 50 MG / 12 MG Chewable Tablet
  • RxCUI: 2281743 - moxidectin 0.24 MG / pyrantel pamoate 50 MG / sarolaner 12 MG Chewable Tablet [Simparica TRIO]
  • RxCUI: 2281743 - Simparica TRIO (moxidectin 0.24 MG / pyrantel pamoate 50 MG / sarolaner 12 MG) Chewable Tablet
  • RxCUI: 2281747 - moxidectin 0.48 MG / pyrantel pamoate 100 MG / sarolaner 24 MG Chewable Tablet

Clinical Specifications

Proprietary Name
Sarolaner, Moxidectin, And Pyrantel
Non-Proprietary Name
Sarolaner, Moxidectin, And Pyrantel
Substance Name
Moxidectin; Pyrantel Pamoate; Sarolaner
Dosage Form
Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
Active Ingredient(s)
Usage Information
SIMPARICA TRIO is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina) and hookworm (L4, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala) infections. SIMPARICA TRIO kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations, and the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (blacklegged tick), and Rhipicephalus sanguineus (brown dog tick) for one month in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds or greater. SIMPARICA TRIO is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.

Regulatory & Marketing

Labeler Name
Zoetis Inc.
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
02-19-2020
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54771-2684-0 identifies a specific commercial package of 30 tablet, chewable in 1 drum of Sarolaner, Moxidectin, And Pyrantel (UNFINISHED drug), drug for further processing labeled by Zoetis Inc.. This tablet, chewable is formulated for use and contains moxidectin; pyrantel pamoate; sarolaner as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Zoetis Inc. on February 19, 2020. The current certification is valid through December 31, 2027.

How is this Zoetis Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54771268400. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
54771-2684-0
11-Digit CMS (5-4-2)
54771-2684-00

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.