NDC 50383-249 Bromfenac

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
50383-249
Proprietary Name:
Bromfenac
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Akorn
Labeler Code:
50383
Start Marketing Date: [9]
01-22-2014
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330 - CLEAR, YELLOW TO ORANGE YELLOW)

Product Packages

NDC Code 50383-249-71

Package Description: 1 BOTTLE, DROPPER in 1 CARTON / 1.7 mL in 1 BOTTLE, DROPPER

Price per Unit: $77.16961 per ML

Product Details

What is NDC 50383-249?

The NDC code 50383-249 is assigned by the FDA to the product Bromfenac which is product labeled by Akorn. The product's dosage form is . The product is distributed in a single package with assigned NDC code 50383-249-71 1 bottle, dropper in 1 carton / 1.7 ml in 1 bottle, dropper. 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 Bromfenac?

Bromfenac Ophthalmic Solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

Which are Bromfenac UNII Codes?

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

Which are Bromfenac 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 Bromfenac?

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:
  • RxCUI: 578018 - bromfenac 0.09 % Ophthalmic Solution
  • RxCUI: 578018 - bromfenac 0.9 MG/ML Ophthalmic Solution
  • RxCUI: 578018 - bromfenac 0.9 MG/ML (bromfenac sodium 1.035 MG/ML) Ophthalmic Solution

* Please review the disclaimer below.

Patient Education

Bromfenac Ophthalmic


Bromfenac ophthalmic is used to treat eye swelling and redness (inflammation) and pain that can occur after cataract surgery. Bromfenac ophthalmic is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the release of certain natural substances that cause pain and swelling.
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* 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.

[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".