Theophylline Anhydrous Powder
NDC Package 58624-0713-0

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.

Theophylline Anhydrous powders is theophylline is used to treat lung diseases such as asthma and COPD (bronchitis, emphysema). This formulation utilizes a powder delivery system. Marketed by Shandong Xinhua Pharmaceutical Company Limited, this product is identified by NDC 58624-0713.

Identification & Billing

NDC Package Code
58624-0713-0
Package Description
25 kg in 1 CARTON
Product Code
58624-0713
11-Digit Billing Format
58624071300

Clinical Specifications

Proprietary Name
Theophylline Anhydrous
Non-Proprietary Name
Theophylline Anhydrous
Substance Name
Theophylline
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)
THEOPHYLLINE 1 kg/kg
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
Shandong Xinhua Pharmaceutical Company Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
01-19-2026
Listing Expiration
12-31-2027
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 58624-0713-0 identifies a specific commercial package of 25 kg in 1 carton of Theophylline Anhydrous (UNFINISHED drug), a bulk ingredient labeled by Shandong Xinhua Pharmaceutical Company Limited. This powder is formulated for use and contains theophylline 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 Shandong Xinhua Pharmaceutical Company Limited on January 19, 2026. The current certification is valid through December 31, 2027.

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 Shandong Xinhua Pharmaceutical Company Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58624071300. 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)
58624-0713-0
11-Digit CMS (5-4-2)
58624-0713-00

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