Theophylline Tablet, Extended Release
NDC Package 62332-026-71

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

Package Information

Theophylline tablets is theophylline is used to treat lung diseases such as asthma and COPD (bronchitis, emphysema). This formulation utilizes a tablet, extended release delivery system. Marketed by Alembic Pharmaceuticals Inc., this product is identified by NDC 62332-026 and is authorized under FDA application ANDA090430.

Identification & Billing

NDC Package Code
62332-026-71
Package Description
500 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
62332-026
11-Digit Billing Format
62332002671
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Theophylline
Non-Proprietary Name
Theophylline
Substance Name
Theophylline Anhydrous
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
THEOPHYLLINE ANHYDROUS 450 mg/1
Pharmacologic Class
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
Alembic Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA090430
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-29-2016
Listing Expiration
12-31-2026
Exclude Flag
N
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (62332-026). Click a package code to view its specific billing and regulatory data.

62332-026-30
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
62332-026-31
100 TABLET, EXTENDED RELEASE in 1 BOTTLE

* 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 62332-026-71 identifies a specific commercial package of 500 tablet, extended release in 1 bottle of Theophylline, a human prescription drug labeled by Alembic Pharmaceuticals Inc.. This tablet, extended release is formulated for oral use and contains theophylline anhydrous 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 Alembic Pharmaceuticals Inc. on January 29, 2016. The current certification is valid through December 31, 2026.

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 Alembic Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62332002671. 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)
62332-026-71
11-Digit CMS (5-4-2)
62332-0026-71

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