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  4. NDC Product Code: 43598-921 Xeglyze

NDC 43598-921 Xeglyze

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 43598-921?
  4. Xeglyze Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing expired due to lack of listing certification.

Get all the details for National Drug Code (NDC) 43598-921 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
43598-921
Proprietary Name:
Xeglyze
Product Type: [3]
Labeler Name: [5]
Dr. Reddy's Laboratories Inc.
Labeler Code:
43598
Product Label ID:
4fe38e95-8738-a28f-4079-43eff7318cb9
FDA Application Number: [6]
NDA206966
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
01-29-2021
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
U
Code Navigator:

Code Structure Chart

Product Details

What is NDC 43598-921?

The NDC code 43598-921 is assigned by the FDA to the product Xeglyze which is product labeled by Dr. Reddy's Laboratories Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 43598-921-11 1 bottle in 1 carton / 200 g in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Xeglyze?

XEGLYZE is indicated for the topical treatment of head lice infestation in patients 6 months of age and older. XEGLYZE should be used in the context of an overall lice management program:Wash (with hot water) or dry-clean all recently worn clothing, hats, used bedding and towelsWash personal care items such as combs, brushes, and hair clips in hot waterUse a fine-tooth comb or special nit comb to remove dead lice and nits

Which are Xeglyze UNII Codes?

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

Which are Xeglyze Inactive Ingredients 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:

What is the NDC to RxNorm Crosswalk for Xeglyze?

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:

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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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".