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  5. NDC Package Code: 63592-7600-0 Olodaterol Hcl

NDC Package 63592-7600-0 Olodaterol Hcl

Powder - View Billable Units, 11-Digit Format, RxNorm

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.

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:
63592-7600-0
Package Description:
.5 kg in 1 DRUM
Product Code:
63592-7600
Non-Proprietary Name:
Olodaterol Hcl
Substance Name:
Olodaterol Hydrochloride
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.
11-Digit NDC Billing Format:
63592760000
Product Type:
Bulk Ingredient
Labeler Name:
Sicor De Mexico S.a. De C.v
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
    • Sample Package:
    N/A
    Marketing Category:
    BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
    Start Marketing Date:
    02-23-2023
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    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.

    Frequently Asked Questions

    What is NDC 63592-7600-0?

    The NDC Packaged Code 63592-7600-0 is assigned to an UNFINISHED drug package of .5 kg in 1 drum of Olodaterol Hcl, a bulk ingredient labeled by Sicor De Mexico S.a. De C.v. The product's dosage form is powder and is administered via form.

    Is NDC 63592-7600 included in the NDC Directory?

    Yes, Olodaterol Hcl is an UNFINISHED PRODUCT with code 63592-7600 that is active and included in the NDC Directory. The product was first marketed by Sicor De Mexico S.a. De C.v on February 23, 2023 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 63592-7600-0?

    The 11-digit format is 63592760000. 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 5-4-1 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
    5-4-163592-7600-05-4-263592-7600-00