Spiriva Capsule
NDC Package 0597-0075-41

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 (tiotropium bromide) capsules is tiotropium is used to control and prevent symptoms (such as wheezing, shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis and emphysema). This formulation utilizes a capsule delivery system. Marketed by Boehringer Ingelheim Pharmaceuticals, Inc., this product is identified by NDC 0597-0075 and is authorized under FDA application NDA021395.

Identification & Billing

NDC Package Code
0597-0075-41
Package Description
3 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK
Product Code
0597-0075
11-Digit Billing Format
00597007541
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Spiriva Handihaler
Non-Proprietary Name
Tiotropium Bromide
Substance Name
Tiotropium Bromide Monohydrate
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
  • Oral - Administration to or by way of the mouth.
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
TIOTROPIUM BROMIDE MONOHYDRATE 18 ug/1
Pharmacologic Class
Usage Information
Tiotropium is used to control and prevent symptoms (such as wheezing, 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. 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 #
NDA021395
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-11-2005
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 (0597-0075). Click a package code to view its specific billing and regulatory data.

0597-0075-47
9 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK
0597-0075-75
1 BLISTER PACK in 1 CARTON / 5 CAPSULE in 1 BLISTER PACK

* 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 0597-0075-41 identifies a specific commercial package of 3 blister pack in 1 carton / 10 capsule in 1 blister pack of Spiriva Handihaler, a human prescription drug labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. This capsule is formulated for oral; respiratory (inhalation) use and contains 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 October 11, 2005. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Tiotropium is used to control and prevent symptoms (such as wheezing, 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. 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: 00597007541. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 total billable units per package. 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)
0597-0075-41
11-Digit CMS (5-4-2)
00597-0075-41

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