Fenbendazole 222 Mg Capsule
NDC 85130-100
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Fenbendazole 222 Mg is a UNAPPROVED DRUG OTHER-approved product labeled by B & L Healthcare Products Inc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white capsule for oral administration. This product entry covers the primary NDC 85130-100 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
85130-100
Proprietary Name:
Fenbendazole 222 Mg
Non-Proprietary Name: [1]
Fenbendazole 222 Mg
Substance Name: [2]
Fenbendazole
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Capsule
- A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
85130
Product Label ID:
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Marketing Timeline
Start Marketing Date: [9]
01-01-2015
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Product Characteristics
Color(s):
WHITE (C48325)
Shape:
CAPSULE (C48336)
Size(s):
5 MM
Score:
1
Code Structure Chart
Product Details
What is NDC 85130-100?
The NDC code 85130-100 is assigned by the FDA to the product Fenbendazole 222 Mg. This pharmaceutical product is labeled by B & L Healthcare Products Inc and is currently categorized as listed product. The medication is a capsule administered via oral route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 85130-100-01, 85130-100-02. 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?
Dewormer
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.
- FENBENDAZOLE 299.35 mg/mol - Antinematodal benzimidazole used in veterinary medicine.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- FENBENDAZOLE (UNII: 621BVT9M36)
- FENBENDAZOLE (UNII: 621BVT9M36) (Active Moiety)
Which are the Inactive Ingredients associated UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- IVERMECTIN (UNII: 8883YP2R6D)
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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 are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
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".
