Olodaterol Hcl Powder
NDC Package 63592-7600-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Olodaterol Hcl powders is olodaterol 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 powder delivery system. Marketed by Sicor De Mexico S.a. De C.v, this product is identified by NDC 63592-7600.

Identification & Billing

NDC Package Code
63592-7600-0
Package Description
.5 kg in 1 DRUM
Product Code
63592-7600
11-Digit Billing Format
63592760000

Clinical Specifications

Proprietary Name
Olodaterol Hcl
Non-Proprietary Name
Olodaterol Hcl
Substance Name
Olodaterol Hydrochloride
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
OLODATEROL HYDROCHLORIDE 1 kg/kg
Usage Information
Olodaterol 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). Olodaterol belongs to the class of drugs known as long-acting beta agonists (LABAs). Olodaterol 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 olodaterol. You should always have a quick-relief inhaler with you. 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.

Regulatory & Marketing

Labeler Name
Sicor De Mexico S.a. De C.v
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
02-23-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 63592-7600-0 identifies a specific commercial package of .5 kg in 1 drum of Olodaterol Hcl (UNFINISHED drug), a bulk ingredient labeled by Sicor De Mexico S.a. De C.v. This powder is formulated for use and contains olodaterol hydrochloride 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 Sicor De Mexico S.a. De C.v on February 23, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Olodaterol 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). Olodaterol belongs to the class of drugs known as long-acting beta agonists (LABAs). Olodaterol 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 olodaterol. You should always have a quick-relief inhaler with you. 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.

How is this Sicor De Mexico S.a. De C.v product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63592760000. 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 (5-4-1)
63592-7600-0
11-Digit CMS (5-4-2)
63592-7600-00

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