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  4. NDC Product Code: 81877-645 Diclareal Topical Kit

NDC 81877-645 Diclareal Topical Kit

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 81877-645?
  5. Diclareal Topical Kit Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

This product is EXCLUDED from the official NDC directory .
NDC Product Code:
81877-645
Proprietary Name:
Diclareal Topical Kit
Product Type: [3]
Labeler Name: [5]
Forreal Pharmaceuticals Llc
Labeler Code:
81877
Product Label ID:
11fe93a7-2c2f-4fdd-8324-760761fb3563
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date: [9]
10-12-2023
End Marketing Date: [10]
06-07-2024
Listing Expiration Date: [11]
06-07-2024
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)

Code Structure Chart

Product Details

What is NDC 81877-645?

The NDC code 81877-645 is assigned by the FDA to the product Diclareal Topical Kit which is product labeled by Forreal Pharmaceuticals Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 81877-645-12 1 kit in 1 kit * 1 bottle in 1 carton (13107-269-47) / 112 g in 1 bottle * 1 tube in 1 carton (0536-2525-25) / 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 Diclareal Topical Kit?

Diclofenac sodium topical solution is indicated for the treatment of the pain of osteoarthritis of the knee(s).

Which are Diclareal Topical Kit UNII Codes?

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

Which are Diclareal Topical Kit 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:

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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.

[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".