Arformoterol Tartrate Inhalation Solution
NDC Package 76204-026-55

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

Arformoterol Tartrate Inhalation Solution solution is arformoterol is used as a long-term (maintenance) treatment to prevent and decrease wheezing and shortness of breath caused by breathing problems (such as chronic obstructive pulmonary disease, including chronic bronchitis and emphysema). This formulation utilizes a solution delivery system. Marketed by Ritedose Pharmaceuticals, Llc, this product is identified by NDC 76204-026 and is authorized under FDA application ANDA214736.

Identification & Billing

NDC Package Code
76204-026-55
Package Description
12 POUCH in 1 CARTON / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE
Product Code
76204-026
11-Digit Billing Format
76204002655
RxNorm Crosswalk
  • RxCUI: 668956 - arformoterol tartrate 15 MCG in 2 ML Inhalation Solution
  • RxCUI: 668956 - arformoterol 0.0075 MG/ML Inhalation Solution
  • RxCUI: 668956 - arformoterol 0.0075 MG/ML (arformoterol tartrate 0.011 MG/ML) Inhalation Solution
  • RxCUI: 668956 - arformoterol 15 MCG per 2 ML Inhalation Solution

Clinical Specifications

Proprietary Name
Arformoterol Tartrate Inhalation Solution
Non-Proprietary Name
Arformoterol Tartrate Inhalation Solution
Substance Name
Arformoterol Tartrate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
ARFORMOTEROL TARTRATE 15 ug/2mL
Pharmacologic Class
Usage Information
Arformoterol is used as a long-term (maintenance) treatment to prevent and decrease wheezing and shortness of breath caused by breathing problems (such as chronic obstructive pulmonary disease, including chronic bronchitis and emphysema). Arformoterol belongs to the class of drugs known as long-acting beta agonists (LABAs). Arformoterol is also known as a bronchodilator. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Controlling symptoms of breathing problems can decrease time lost from work or school. This medication does not work right away and should not be used for sudden attacks of breathing trouble. Your doctor must prescribe a quick-relief medicine/inhaler (such as albuterol, also known as salbutamol) for sudden shortness of breath while you are using arformoterol. You should always have a quick-relief inhaler with you. Arformoterol is not approved to treat asthma. People with asthma using long-acting inhaled beta agonists (such as arformoterol) without also using an inhaled corticosteroid may have an increased risk of serious (sometimes fatal) breathing problems.

Regulatory & Marketing

Labeler Name
Ritedose Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA214736
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-27-2023
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 (76204-026). Click a package code to view its specific billing and regulatory data.

76204-026-01
30 POUCH in 1 CARTON / 1 AMPULE in 1 POUCH / 2 mL in 1 AMPULE
76204-026-02
60 POUCH in 1 CARTON / 1 AMPULE in 1 POUCH / 2 mL in 1 AMPULE

* 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 76204-026-55 identifies a specific commercial package of 12 pouch in 1 carton / 5 ampule in 1 pouch / 2 ml in 1 ampule of Arformoterol Tartrate Inhalation Solution, a human prescription drug labeled by Ritedose Pharmaceuticals, Llc. This solution is formulated for respiratory (inhalation) use and contains arformoterol tartrate 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 Ritedose Pharmaceuticals, Llc on February 27, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Arformoterol is used as a long-term (maintenance) treatment to prevent and decrease wheezing and shortness of breath caused by breathing problems (such as chronic obstructive pulmonary disease, including chronic bronchitis and emphysema). Arformoterol belongs to the class of drugs known as long-acting beta agonists (LABAs). Arformoterol is also known as a bronchodilator. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Controlling symptoms of breathing problems can decrease time lost from work or school. This medication does not work right away and should not be used for sudden attacks of breathing trouble. Your doctor must prescribe a quick-relief medicine/inhaler (such as albuterol, also known as salbutamol) for sudden shortness of breath while you are using arformoterol. You should always have a quick-relief inhaler with you. Arformoterol is not approved to treat asthma. People with asthma using long-acting inhaled beta agonists (such as arformoterol) without also using an inhaled corticosteroid may have an increased risk of serious (sometimes fatal) breathing problems.

How is this Ritedose Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76204002655. 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 (5-3-2)
76204-026-55
11-Digit CMS (5-4-2)
76204-0026-55

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