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  4. NDC Product Code: 21695-153 Xopenex

NDC 21695-153 Xopenex

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 21695-153?
  4. Xopenex Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
21695-153
Proprietary Name:
Xopenex
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Rebel Distributors Corp
Labeler Code:
21695
Product Label ID:
35eb525b-72a5-4ef9-a36a-531e9e6b3560
Start Marketing Date: [9]
04-01-1999
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 21695-153-24

Package Description: 2 POUCH in 1 CARTON / 12 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE

Product Details

What is NDC 21695-153?

The NDC code 21695-153 is assigned by the FDA to the product Xopenex which is product labeled by Rebel Distributors Corp. The product's dosage form is . The product is distributed in a single package with assigned NDC code 21695-153-24 2 pouch in 1 carton / 12 vial, single-dose in 1 pouch / 3 ml in 1 vial, single-dose. 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 Xopenex?

Levalbuterol is used to treat wheezing and shortness of breath that commonly occur with lung problems (such as asthma, chronic obstructive pulmonary disease). It is a quick-relief drug. Controlling these symptoms can decrease time lost from work or school. Levalbuterol belongs to a class of drugs known as bronchodilators. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily.

Which are Xopenex UNII Codes?

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

Which are Xopenex 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 Xopenex?

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: 242754 - levalbuterol HCl 1.25 MG in 3 ML Inhalation Solution
  • RxCUI: 242754 - levalbuterol 0.417 MG/ML Inhalation Solution
  • RxCUI: 242754 - levalbuterol 1.25 MG (as levalbuterol HCl 1.44 MG) per 3 ML Inhalation Solution
  • RxCUI: 833470 - Xopenex 1.25 MG in 3 ML Inhalation Solution
  • RxCUI: 833470 - levalbuterol 0.417 MG/ML Inhalation Solution [Xopenex]

* 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".