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  4. NDC Product Code: 0168-0457 Fluocinonide

NDC 0168-0457 Fluocinonide

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0168-0457?
  4. Fluocinonide Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory .
NDC Product Code:
0168-0457
Proprietary Name:
Fluocinonide
Product Type: [3]
Labeler Name: [5]
E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.
Labeler Code:
0168
Product Label ID:
651fb7fd-0441-4c30-947f-86751d6b97c0
FDA Application Number: [6]
ANDA200735
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
07-14-2014
End Marketing Date: [10]
03-31-2020
Listing Expiration Date: [11]
03-31-2020
Exclude Flag: [12]
D
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Product Details

What is NDC 0168-0457?

The NDC code 0168-0457 is assigned by the FDA to the product Fluocinonide which is product labeled by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 0168-0457-04 1 tube in 1 carton / 120 g in 1 tube, 0168-0457-30 1 tube in 1 carton / 30 g in 1 tube, 0168-0457-60 1 tube in 1 carton / 60 g in 1 tube. 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 Fluocinonide?

This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Fluocinonide reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a strong corticosteroid.

Which are Fluocinonide UNII Codes?

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

Which are Fluocinonide 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:

* Please review the disclaimer below.

Patient Education

Fluocinolone Topical


Fluocinolone topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Fluocinolone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
[Learn More]


Fluocinonide Topical


Fluocinonide topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Fluocinonide is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
[Learn More]


* Please review the disclaimer below.

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.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".