Spiriva Respimat Spray, Metered
NDC Package 0597-0100-28

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Spiriva Respimat (tiotropium bromide inhalation spray) sprays is tiotropium is used to treat lung diseases such as asthma and COPD (bronchitis, emphysema). This formulation utilizes a spray, metered delivery system. Marketed by Boehringer Ingelheim Pharmaceuticals, Inc., this product is identified by NDC 0597-0100 and is authorized under FDA application NDA021936.

Identification & Billing

NDC Package Code
0597-0100-28
Package Description
1 CARTRIDGE in 1 CARTON / 28 SPRAY, METERED in 1 CARTRIDGE
Product Code
0597-0100
11-Digit Billing Format
00597010028
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
RxNorm Crosswalk
  • RxCUI: 1552002 - tiotropium bromide 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 60 ACTUATS
  • RxCUI: 1552002 - 60 ACTUAT tiotropium 0.0025 MG/ACTUAT Inhalation Spray
  • RxCUI: 1552002 - tiotropium 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 60 ACTUATS
  • RxCUI: 1552004 - Spiriva Respimat 2.5 MCG/ACTUAT Metered Dose Inhalation Spray, 60 ACTUAT
  • RxCUI: 1552004 - 60 ACTUAT tiotropium 0.0025 MG/ACTUAT Inhalation Spray [Spiriva]

Clinical Specifications

Proprietary Name
Spiriva Respimat
Non-Proprietary Name
Tiotropium Bromide Inhalation Spray
Substance Name
Tiotropium Bromide Anhydrous
Dosage Form
Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.
Administration Route
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
TIOTROPIUM BROMIDE ANHYDROUS 3.124 ug/1
Pharmacologic Class
Usage Information
Tiotropium is used to treat lung diseases such as asthma and COPD (bronchitis, emphysema). It must be used regularly to prevent wheezing and shortness of breath. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Tiotropium belongs to a class of drugs known as anticholinergics. Controlling symptoms of breathing problems can decrease time lost from work or school. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden breathing problems. If wheezing or sudden shortness of breath occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.

Regulatory & Marketing

Labeler Name
Boehringer Ingelheim Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021936
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-30-2014
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0597-0100). Click a package code to view its specific billing and regulatory data.

0597-0100-51
1 CARTRIDGE in 1 CARTON / 10 SPRAY, METERED in 1 CARTRIDGE
0597-0100-61
1 CARTRIDGE in 1 CARTON / 60 SPRAY, METERED in 1 CARTRIDGE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0597-0100-28 identifies a specific commercial package of 1 cartridge in 1 carton / 28 spray, metered in 1 cartridge of Spiriva Respimat, a human prescription drug labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. This spray, metered is formulated for respiratory (inhalation) use and contains tiotropium bromide anhydrous as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Boehringer Ingelheim Pharmaceuticals, Inc. on September 30, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Tiotropium is used to treat lung diseases such as asthma and COPD (bronchitis, emphysema). It must be used regularly to prevent wheezing and shortness of breath. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Tiotropium belongs to a class of drugs known as anticholinergics. Controlling symptoms of breathing problems can decrease time lost from work or school. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden breathing problems. If wheezing or sudden shortness of breath occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.

How is this Boehringer Ingelheim Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00597010028. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0597-0100-28
11-Digit CMS (5-4-2)
00597-0100-28

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.