Sarolaner, Moxidectin, And Pyrantel Tablet, Chewable
NDC 54771-2669

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54771-2669?
  5. Sarolaner, Moxidectin, And Pyrantel Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product 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 is a DRUG FOR FURTHER PROCESSING-approved product labeled by Zoetis Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a brown tablet, chewable. This product entry covers the primary NDC 54771-2669 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
54771-2669
Proprietary Name:
Sarolaner, Moxidectin, And Pyrantel
Non-Proprietary Name: [1]
Sarolaner, Moxidectin, And Pyrantel
Substance Name: [2]
Moxidectin; Pyrantel Pamoate; Sarolaner
NDC Directory Status:
Drug For Further Processing
Product Type: [3]
UNFINISHED PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

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.

Labeler & Regulatory Data

Labeler Name: [5]
Zoetis Inc.
Labeler Code:
54771
Product Label ID:
0f83bcf4-7e89-479f-a980-4cb40456ee78
Marketing Category: [8]
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.

Marketing Timeline

Start Marketing Date: [9]
02-19-2020
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes

Product Characteristics

Color(s):
BROWN (C48332 - REDDISH BROWN)
Shape:
PENTAGON (5 SIDED) (C48346)
Size(s):
9 MM
11 MM
14 MM
17 MM
Score:
1

Code Structure Chart

Product Details

What is NDC 54771-2669?

The NDC code 54771-2669 is assigned by the FDA to the product Sarolaner, Moxidectin, And Pyrantel. It is commonly known by its generic name, sarolaner, moxidectin, and pyrantel. This pharmaceutical product is labeled by Zoetis Inc. and is currently categorized as listed product. The medication is a tablet, chewable. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 54771-2669-0. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

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Product & Regulatory Definitions
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.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
What is an Unfinished Product? This field indicates if the product is an unfinished drug. An unfinished drug is an active pharmaceutical ingredient either alone or with other ingredients that is not a finished drug product. Unfinished drugs are used to process other drugs or for drug compounding.