NDC 76519-1171 Albuterol Sulfate Hfa

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:
76519-1171
Proprietary Name:
Albuterol Sulfate Hfa
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
H.j. Harkins Company, Inc.
Labeler Code:
76519
Start Marketing Date: [9]
03-25-2019
Listing Expiration Date: [11]
12-31-2021
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 76519-1171-0

Package Description: 8.5 g in 1 INHALER

Product Details

What is NDC 76519-1171?

The NDC code 76519-1171 is assigned by the FDA to the product Albuterol Sulfate Hfa which is product labeled by H.j. Harkins Company, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 76519-1171-0 8.5 g in 1 inhaler . 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 Albuterol Sulfate Hfa?

Albuterol (also known as salbutamol) is used to treat wheezing and shortness of breath caused by breathing problems such as asthma. It is a quick-relief medication. Albuterol 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. Controlling symptoms of breathing problems can decrease time lost from work or school.

Which are Albuterol Sulfate Hfa UNII Codes?

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

What is the NDC to RxNorm Crosswalk for Albuterol Sulfate Hfa?

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: 2123072 - albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAir
  • RxCUI: 2123072 - NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler
  • RxCUI: 2123072 - albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAir

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Patient Education

Albuterol Oral Inhalation


Albuterol is used to prevent and treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by lung diseases such as asthma and chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways). Albuterol inhalation aerosol and powder for oral inhalation is also used to prevent breathing difficulties during exercise. Albuterol inhalation aerosol (Proair HFA, Proventil HFA, Ventolin HFA) is used in adults and children 4 years of age and older. Albuterol powder for oral inhalation (Proair Respiclick) is used in children 12 years of age and older. Albuterol solution for oral inhalation is used in adults and children 2 years of age and older. Albuterol is in a class of medications called bronchodilators. It works by relaxing and opening air passages to the lungs to make breathing easier.
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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".