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  4. NDC Product Code: 50383-265 Loteprednol Etabonate

NDC 50383-265 Loteprednol Etabonate

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 50383-265?
  5. Loteprednol Etabonate Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. 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:
50383-265
Proprietary Name:
Loteprednol Etabonate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Akorn
Labeler Code:
50383
Product Label ID:
66977c58-1e0c-4add-8ff1-c90050dbcd10
Start Marketing Date: [9]
04-18-2019
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF WHITE)

Code Structure Chart

Product Details

What is NDC 50383-265?

The NDC code 50383-265 is assigned by the FDA to the product Loteprednol Etabonate which is product labeled by Akorn. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 50383-265-05 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper, 50383-265-10 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper, 50383-265-15 1 bottle, dropper in 1 carton / 15 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 Loteprednol Etabonate?

This medication is used to treat certain eye conditions due to inflammation or injury. It is also used after eye surgery. Loteprednol works by relieving symptoms such as swelling, redness, and itching. It belongs to a class of drugs known as corticosteroids.

Which are Loteprednol Etabonate UNII Codes?

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

Which are Loteprednol Etabonate 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 Loteprednol Etabonate?

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: 311382 - loteprednol etabonate 0.5 % Ophthalmic Suspension
  • RxCUI: 311382 - loteprednol etabonate 5 MG/ML Ophthalmic Suspension

* Please review the disclaimer below.

Patient Education

Loteprednol Ophthalmic


Ophthalmic loteprednol products are used to treat different eye conditions: Loteprednol (Inveltys, Lotemax, Lotemax SM) is used to treat swelling and pain after cataract surgery (procedure to treat clouding of the lens in the eye). Loteprednol (Alrex) is used to reduce eye redness, itching, and swelling caused by seasonal allergies. Loteprednol (Lotemax) is used to reduce eye swelling caused by allergies, certain eye infections, ocular rosacea (condition that can cause swelling, redness, and itching of the eye), herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past and can affect the eyes), and other eye conditions. Loteprednol (Eysuvis) is used to treat dry eye disease (an eye disorder in which tears do not provide sufficient eye lubrication). Loteprednol is in a class of medications called corticosteroids. It works by stopping the release of certain natural substances that cause swelling, itching, and pain.
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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".