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  5. NDC Package Code: 0597-0075-41 Spiriva Handihaler

NDC Package 0597-0075-41 Spiriva Handihaler

Tiotropium Bromide Capsule Oral; Respiratory (inhalation) - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0597-0075-41
Package Description:
3 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK
Product Code:
0597-0075
Proprietary Name:
Spiriva Handihaler
Non-Proprietary Name:
Tiotropium Bromide
Substance Name:
Tiotropium Bromide Monohydrate
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.
11-Digit NDC Billing Format:
00597007541
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
3 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 485032 - tiotropium 18 MCG Inhalation Powder
  • RxCUI: 485032 - tiotropium 0.018 MG Inhalation Powder
  • RxCUI: 485032 - tiotropium 18 MCG (tiotropium bromide 22.5 MCG) Inhalation Powder
  • RxCUI: 580261 - SPIRIVA HandiHaler 18 MCG Inhalation Powder
  • RxCUI: 580261 - tiotropium 0.018 MG Inhalation Powder [Spiriva]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Boehringer Ingelheim Pharmaceuticals, Inc.
    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(s):
  • 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(es):
  • Anticholinergic - [EPC] (Established Pharmacologic Class)
  • Cholinergic Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA021395
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    10-11-2005
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0597-0075-479 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK
    0597-0075-751 BLISTER PACK in 1 CARTON / 5 CAPSULE in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0597-0075-41?

    The NDC Packaged Code 0597-0075-41 is assigned to a 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.. The product's dosage form is capsule and is administered via oral; respiratory (inhalation) form.

    Is NDC 0597-0075 included in the NDC Directory?

    Yes, Spiriva Handihaler with product code 0597-0075 is active and included in the NDC Directory. The product was first marketed by Boehringer Ingelheim Pharmaceuticals, Inc. on October 11, 2005 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0597-0075-41?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 3.

    What is the 11-digit format for NDC 0597-0075-41?

    The 11-digit format is 00597007541. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20597-0075-415-4-200597-0075-41