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  5. NDC Package Code: 53183-0544-1 Formoterol Fumarate Dihydrate Cr

NDC Package 53183-0544-1 Formoterol Fumarate Dihydrate Cr

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:
53183-0544-1
Package Description:
1 kg in 1 CARTON
Product Code:
53183-0544
Non-Proprietary Name:
Formoterol Fumarate Dihydrate Cr
Substance Name:
Formoterol Fumarate
Usage Information:
Formoterol is used as a long-term (maintenance) treatment to prevent or decrease breathing problems caused by ongoing lung diseases (chronic obstructive pulmonary disease-COPD, including chronic bronchitis and emphysema). Formoterol belongs to the class of drugs known as long-acting inhaled beta-agonists (LABAs). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. This effect helps to reduce wheezing, coughing, and shortness of breath. 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 inhaler (e.g., albuterol, also called salbutamol in some countries) for sudden shortness of breath while you are using formoterol. You should always have a quick-relief inhaler with you. This form of formoterol is not approved to treat asthma. People with asthma using long-acting inhaled beta agonists (such as formoterol) without also using an inhaled corticosteroid may have an increased risk of serious (sometimes fatal) breathing problems.
11-Digit NDC Billing Format:
53183054401
Product Type:
Bulk Ingredient
Labeler Name:
Sicor S.r.l.
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):
FORMOTEROL FUMARATE 100 kg/100kg
Sample Package:
N/A
Marketing Category:
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date:
02-01-2008
Listing Expiration Date:
12-31-2025
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 53183-0544-1?

The NDC Packaged Code 53183-0544-1 is assigned to an UNFINISHED drug package of 1 kg in 1 carton of Formoterol Fumarate Dihydrate Cr, a bulk ingredient labeled by Sicor S.r.l.. The product's dosage form is powder and is administered via form.

Is NDC 53183-0544 included in the NDC Directory?

Yes, Formoterol Fumarate Dihydrate Cr is an UNFINISHED PRODUCT with code 53183-0544 that is active and included in the NDC Directory. The product was first marketed by Sicor S.r.l. on February 01, 2008 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 53183-0544-1?

The 11-digit format is 53183054401. 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
5-4-153183-0544-15-4-253183-0544-01