Stiolto Respimat Spray, Metered
NDC Package 0597-0155-28

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

Stiolto Respimat (tiotropium bromide and olodaterol) sprays is a medication used to control and prevent symptoms (such as wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). This formulation utilizes a spray, metered delivery system. Marketed by Boehringer Ingelheim Pharmaceuticals, Inc., this product is identified by NDC 0597-0155 and is authorized under FDA application NDA206756.

Identification & Billing

NDC Package Code
0597-0155-28
Package Description
1 CARTRIDGE in 1 CARTON / 28 SPRAY, METERED in 1 CARTRIDGE
Product Code
0597-0155
11-Digit Billing Format
00597015528
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
RxNorm Crosswalk
  • RxCUI: 1651266 - tiotropium 2.5 MCG / olodaterol 2.5 MCG per ACTUAT Metered Dose Inhalation Spray 28 ACTUAT
  • RxCUI: 1651266 - 28 ACTUAT olodaterol 0.0025 MG/ACTUAT / tiotropium 0.0025 MG/ACTUAT Inhalation Spray
  • RxCUI: 1651266 - olodaterol 2.5 MCG (as olodaterol HCl 2.736 MCG) / tiotropium 2.5 MCG (as tiotropium bromide 3.124 MCG) per ACTUAT Metered Dose Inhalation Spray, 28 ACTUAT
  • RxCUI: 1651266 - olodaterol 2.5 MCG / tiotropium 2.5 MCG per ACTUAT Metered Dose Inhalation Spray, 28 ACTUAT
  • RxCUI: 1651271 - Stiolto Respimat 2.5 MCG/2.5 MCG per INHAL Metered Dose Inhalation Spray, 28 ACTUAT

Clinical Specifications

Proprietary Name
Stiolto Respimat
Non-Proprietary Name
Tiotropium Bromide And Olodaterol
Substance Name
Olodaterol Hydrochloride; Tiotropium Bromide Monohydrate
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)
Pharmacologic Class
Usage Information
This product is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). Controlling symptoms of breathing problems helps you stay active. This inhaler contains 2 medications: tiotropium and olodaterol. Both drugs work 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. Olodaterol belongs to the class of drugs known as long-acting inhaled beta-agonists (LABAs). Both drugs are also known as bronchodilators. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden shortness of breath. If sudden breathing problems occur, use your quick-relief inhaler as prescribed. Tiotropium/olodaterol is not approved to treat asthma. People with asthma using long-acting inhaled beta agonists (such as olodaterol) without also using an inhaled corticosteroid may have an increased risk of serious (sometimes fatal) breathing problems.

Regulatory & Marketing

Labeler Name
Boehringer Ingelheim Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA206756
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-21-2015
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 (0597-0155). Click a package code to view its specific billing and regulatory data.

0597-0155-31
1 CARTRIDGE in 1 CARTON / 28 SPRAY, METERED in 1 CARTRIDGE
0597-0155-61
1 CARTRIDGE in 1 CARTON / 60 SPRAY, METERED in 1 CARTRIDGE
0597-0155-70
1 CARTRIDGE in 1 CARTON / 10 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 0597-0155-28 identifies a specific commercial package of 1 cartridge in 1 carton / 28 spray, metered in 1 cartridge of Stiolto Respimat, a human prescription drug labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. This spray, metered is formulated for respiratory (inhalation) use and contains olodaterol hydrochloride; tiotropium bromide monohydrate 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 May 21, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This product is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). Controlling symptoms of breathing problems helps you stay active. This inhaler contains 2 medications: tiotropium and olodaterol. Both drugs work 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. Olodaterol belongs to the class of drugs known as long-acting inhaled beta-agonists (LABAs). Both drugs are also known as bronchodilators. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden shortness of breath. If sudden breathing problems occur, use your quick-relief inhaler as prescribed. Tiotropium/olodaterol is not approved to treat asthma. People with asthma using long-acting inhaled beta agonists (such as olodaterol) without also using an inhaled corticosteroid may have an increased risk of serious (sometimes fatal) breathing problems.

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: 00597015528. 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)
0597-0155-28
11-Digit CMS (5-4-2)
00597-0155-28

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