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  4. NDC Product Code: 81877-723 Diclofenac Sodium 1% Gel

NDC 81877-723 Diclofenac Sodium 1% Gel

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 81877-723?
  4. Diclofenac Sodium 1% Gel Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 81877-723 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:
81877-723
Proprietary Name:
Diclofenac Sodium 1% Gel
Product Type: [3]
Labeler Name: [5]
Forreal Pharmaceuticals Llc
Labeler Code:
81877
Product Label ID:
1057d1bd-92cb-45aa-aed9-6c045f0764e3
FDA Application Number: [6]
ANDA210986
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
04-15-2024
End Marketing Date: [10]
06-03-2024
Listing Expiration Date: [11]
06-03-2024
Exclude Flag: [12]
D
Code Navigator:

Code Structure Chart

Product Details

What is NDC 81877-723?

The NDC code 81877-723 is assigned by the FDA to the product Diclofenac Sodium 1% Gel 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 81877-723-10 100 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 Diclofenac Sodium 1% Gel?

Use up to 21 days unless directed by your doctorNot for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.Daily For arthritis pain:Use 4 times per day every dayDo not use on more than 2 body areas at the same timePer Dose (Use ENCLOSED DOSING CARD to measure a dose)–For each upper body area (hand, wrist, or elbow) - Squeeze out 2.25 inches (2 grams)–For each lower body area (foot, ankle, or knee) - Squeeze out 4.5 inches (4 grams)Read the enclosed User Guide for complete instructions:use only as directed do not use more than directed or for longer than directed apply only to clean, dry skin that does not have any cuts, open wounds, infections or rashes do not apply in the same area as any other product do not apply with external heat such as heating pad do not apply a bandage over the treated areastore ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1% Arthritis Pain. The dosing card is re-usable.

Which are Diclofenac Sodium 1% Gel UNII Codes?

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

Which are Diclofenac Sodium 1% Gel 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.

[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, 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".