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  5. NDC Package Code: 0597-0155-28 Stiolto Respimat

NDC Package 0597-0155-28 Stiolto Respimat

Tiotropium Bromide And Olodaterol Spray, Metered 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:
0597-0155-28
Package Description:
1 CARTRIDGE in 1 CARTON / 28 SPRAY, METERED in 1 CARTRIDGE
Product Code:
0597-0155
Proprietary Name:
Stiolto Respimat
Non-Proprietary Name:
Tiotropium Bromide And Olodaterol
Substance Name:
Olodaterol Hydrochloride; Tiotropium Bromide Monohydrate
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.
11-Digit NDC Billing Format:
00597015528
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Boehringer Ingelheim Pharmaceuticals Inc.
    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(s):
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
    • Active Ingredient(s):
  • OLODATEROL HYDROCHLORIDE 2.736 ug/1
  • TIOTROPIUM BROMIDE MONOHYDRATE 3.124 ug/1
    • Pharmacologic Class(es):
  • Adrenergic beta2-Agonists - [MoA] (Mechanism of Action)
  • Anticholinergic - [EPC] (Established Pharmacologic Class)
  • Cholinergic Antagonists - [MoA] (Mechanism of Action)
  • beta2-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA206756
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    05-21-2015
    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
    0597-0155-611 CARTRIDGE in 1 CARTON / 60 SPRAY, METERED in 1 CARTRIDGE
    0597-0155-701 CARTRIDGE in 1 CARTON / 10 SPRAY, METERED in 1 CARTRIDGE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0597-0155-28?

    The NDC Packaged Code 0597-0155-28 is assigned to a 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.. The product's dosage form is spray, metered and is administered via respiratory (inhalation) form.

    Is NDC 0597-0155 included in the NDC Directory?

    Yes, Stiolto Respimat with product code 0597-0155 is active and included in the NDC Directory. The product was first marketed by Boehringer Ingelheim Pharmaceuticals Inc. on May 21, 2015 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 11-digit format for NDC 0597-0155-28?

    The 11-digit format is 00597015528. 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
    4-4-20597-0155-285-4-200597-0155-28