Nix
NDC 76413-358

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 76413-358?
  5. Nix Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Nix is a NDA-approved product labeled by Central Texas Community Health Centers. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a orange product. This product entry covers the primary NDC 76413-358 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
76413-358
Proprietary Name:
Nix
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Central Texas Community Health Centers
Labeler Code:
76413
Product Label ID:
ad967f76-6fda-4ac9-a71f-d0603a6ed71e
FDA Application Number: [6]
NDA019918
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
11-15-2013
Listing Expiration Date: [11]
12-31-2020
Exclude Flag: [12]
I

Product Characteristics

Color(s):
ORANGE (C48331 - LIGHT ORANGE)

Code Structure Chart

Product Details

What is NDC 76413-358?

The NDC code 76413-358 is assigned by the FDA to the product Nix. This pharmaceutical product is labeled by Central Texas Community Health Centers and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 76413-358-01. 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?

Inspectall household members should be checked by another person for lice and/or nits (eggs)use a magnifying glass in bright light to help you see the lice and nits (eggs)use a tool, such as a comb or two unsharpened pencils to lift and part the hairlook for tiny nits near the scalp, beginning at the back of the neck and behind the earssmall sections of hair (1-2 inches wide) should be examined at a timeunlike dandruff, nits stick to the hair. Dandruff should move when lightly touched.if either lice or nits (eggs) are found, treat with Nix® Creme RinseTreatwash hair with a shampoo without conditioner. Do not use a shampoo that contains a conditioner or a conditioner alone since this may decrease the activity of Nix®. Rinse with water.towel dry hair so it is damp but not wetshake the bottle of Nix® wellcompletely saturate the hair and scalp with Nix®. Begin to apply Nix® behind the ears and at the back of the neck.keep Nix® out of the eyes. Protect the eyes with a washcloth or towel.leave Nix® on the hair for 10 minutes, but no longerrinse with warm watertowel dry hair and comb out tanglesif live lice are seen seven days or more after the first treatment, a second treatment should be givenRemove Lice/Nitsremove nits by combing the hair with the special small tooth comb provided. Remaining nits may be removed by hand (using a throw-away glove), or cutting the nits out.use the nit comb provided and make sure the hair remains slightly damp while removing nitsif the hair dries during combing, dampen it slightly with waterpart the hair into 4 sections. Work on one section at a time. Longer hair may take more time (1-2 hours).start at the top of the head on the section you have pickedwith one hand, lift a 1-2 inch wide strand of hair. Get the teeth of the comb as close to the scalp as possible and comb with a firm, even motion away from the scalp to the end of the hair.use clips to pin back each strand of hair after you have combed out the nitsclean the comb completely as you go. Wipe the nits from the comb with a tissue and throw away the tissue in a sealed plastic bag to prevent the lice from coming back.after combing, recheck the entire head for nits and repeat combing if necessarycheck the affected head daily to remove any nits that you might have missed

Which are the associated UNII Codes?

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

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:

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:

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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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".