Theophylline
NDC Package 49349-010-02

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Theophylline is used to treat lung diseases such as asthma and COPD (bronchitis, emphysema). Marketed by Remedyrepack Inc., this product is identified by NDC 49349-010 and is authorized under FDA application ANDA089763.

Identification & Billing

NDC Package Code
49349-010-02
Package Description
30 TABLET in 1 BLISTER PACK
Product Code
49349-010
11-Digit Billing Format
49349001002

Clinical Specifications

Proprietary Name
Theophylline Extended Release
Dosage Form
-
Usage Information
Theophylline is used to treat lung diseases such as asthma and COPD (bronchitis, emphysema). It must be used regularly to prevent wheezing and shortness of breath. This medication belongs to a class of drugs known as xanthines. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. It also decreases the lungs' response to irritants. Controlling symptoms of breathing problems can decrease time lost from work or school. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden breathing problems. If sudden shortness of breath occurs, use your quick-relief inhaler as prescribed.

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
FDA Application #
ANDA089763
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-07-2011
End Marketing Date
07-08-2012
Listing Expiration
07-08-2012
Exclude Flag
D
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49349-010-02 identifies a specific commercial package of 30 tablet in 1 blister pack of Theophylline Extended Release, labeled by Remedyrepack 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 Remedyrepack Inc. on July 07, 2011. The current certification is valid through July 08, 2012.

What are the primary indications for this medication?

Theophylline is used to treat lung diseases such as asthma and COPD (bronchitis, emphysema). It must be used regularly to prevent wheezing and shortness of breath. This medication belongs to a class of drugs known as xanthines. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. It also decreases the lungs' response to irritants. Controlling symptoms of breathing problems can decrease time lost from work or school. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden breathing problems. If sudden shortness of breath occurs, use your quick-relief inhaler as prescribed.

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49349001002. 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)
49349-010-02
11-Digit CMS (5-4-2)
49349-0010-02

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