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  4. NDC Product Code: 53002-8410 Atrovent Hfa

NDC 53002-8410 Atrovent Hfa

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 53002-8410?
  4. Atrovent Hfa Uses
  5. Active Ingredients UNII Codes
  6. NDC to RxNorm Crosswalk
  7. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Get all the details for National Drug Code (NDC) 53002-8410 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
53002-8410
Proprietary Name:
Atrovent Hfa
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Rpk Pharmaceuticals, Inc.
Labeler Code:
53002
Product Label ID:
ae462cd6-615b-4f0d-ae6e-59007e7acab0
FDA Application Number: [6]
NDA021527
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
05-01-2005
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
I
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Product Details

What is NDC 53002-8410?

The NDC code 53002-8410 is assigned by the FDA to the product Atrovent Hfa which is product labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 53002-8410-1 1 canister in 1 carton / 200 aerosol, metered in 1 canister. 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 Atrovent Hfa?

Ipratropium is used to control and prevent symptoms (wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis and emphysema). 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. For preventing symptoms of lung disease, this medication must be used regularly to be effective. Use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) for wheezing or sudden shortness of breath unless otherwise directed by your doctor. Ipratropium does not work as fast as your quick-relief inhaler, but may sometimes be used to relieve symptoms of wheezing or sudden shortness of breath if so prescribed by your doctor.

Which are Atrovent Hfa UNII Codes?

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

What is the NDC to RxNorm Crosswalk for Atrovent 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: 836343 - ipratropium bromide 17 MCG/INHAL Metered Dose Inhaler, 200 Actuations
  • RxCUI: 836343 - 200 ACTUAT ipratropium bromide 0.017 MG/ACTUAT Metered Dose Inhaler
  • RxCUI: 836343 - ipratropium bromide 0.017 MG/ACTUAT Metered Dose Inhaler, 200 ACTUAT
  • RxCUI: 836343 - ipratropium bromide 17 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUAT
  • RxCUI: 836368 - Atrovent HFA 17 MCG/INHAL Metered Dose Inhaler, 200 Actuations

* Please review the disclaimer below.

Patient Education

Ipratropium Oral Inhalation


Ipratropium oral inhalation is used to prevent wheezing, shortness of breath, coughing, and chest tightness in people with chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways) such as chronic bronchitis (swelling of the air passages that lead to the lungs) and emphysema (damage to the air sacs in the lungs). Ipratropium is in a class of medications called bronchodilators. It works by relaxing and opening the air passages to the lungs to make breathing easier.
[Learn More]


* 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.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".