Brovana
NDC Package 63402-911-64
Package Information
Brovana 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). Marketed by Sumitomo Pharma America, Inc., this product is identified by NDC 63402-911 and is authorized under FDA application NDA021912.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 63402 - Sumitomo Pharma America, Inc.
- 63402-911 - Brovana
- 63402-911-64 - 15 POUCH in 1 CARTON / 4 VIAL, SINGLE-DOSE in 1 POUCH (63402-911-04) / 2 mL in 1 VIAL, SINGLE-DOSE
- 63402-911 - Brovana
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.
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Billing & HCPCS Mapping
To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.
Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.
* 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 (63402-911). Click a package code to view its specific billing and regulatory data.
* 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 63402-911-64 identifies a specific commercial package of 15 pouch in 1 carton / 4 vial, single-dose in 1 pouch (63402-911-04) / 2 ml in 1 vial, single-dose of Brovana, labeled by Sumitomo Pharma America, Inc.. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Sumitomo Pharma America, Inc. on April 01, 2007. The current certification is valid through January 01, 2024.
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 Sumitomo Pharma America, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 63402091164. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
