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  4. NDC Product Code: 76282-708 Difluprednate

NDC 76282-708 Difluprednate

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 76282-708?
  4. Difluprednate Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
76282-708
Proprietary Name:
Difluprednate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Exelan Pharmaceuticals, Inc.
Labeler Code:
76282
Product Label ID:
f7744cc9-bc5b-4642-8b36-07136704910a
Start Marketing Date: [9]
12-10-2021
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
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Product Details

What is NDC 76282-708?

The NDC code 76282-708 is assigned by the FDA to the product Difluprednate which is product labeled by Exelan Pharmaceuticals, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 76282-708-50 1 bottle in 1 carton / 5 ml 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 Difluprednate?

The use of difluprednate ophthalmic emulsion, as with other ophthalmic corticosteroids, is contraindicated in most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures.

Which are Difluprednate UNII Codes?

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

Which are Difluprednate 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 Difluprednate?

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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Patient Education

Difluprednate Ophthalmic


Difluprednate ophthalmic is used to treat eye swelling and pain after eye surgery. Difluprednate ophthalmic is in a class of medications called corticosteroids. It works by stopping the release of certain natural substances that cause swelling and pain.
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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.

[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 ("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".