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  5. NDC Package Code: 46708-025-31 Theophylline

NDC Package 46708-025-31 Theophylline

Tablet, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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:
46708-025-31
Package Description:
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
46708-025
Proprietary Name:
Theophylline
Non-Proprietary Name:
Theophylline
Substance Name:
Theophylline Anhydrous
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.
11-Digit NDC Billing Format:
46708002531
NDC to RxNorm Crosswalk:
  • RxCUI: 314241 - theophylline 450 MG Extended Release Oral Tablet
  • RxCUI: 317769 - theophylline 300 MG Extended Release Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Alembic Pharmaceuticals Limited
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • THEOPHYLLINE ANHYDROUS 300 mg/1
    • Pharmacologic Class(es):
  • Methylxanthine - [EPC] (Established Pharmacologic Class)
  • Xanthines - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA090430
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-01-2010
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    46708-025-3030 TABLET, EXTENDED RELEASE in 1 BOTTLE
    46708-025-71500 TABLET, EXTENDED RELEASE in 1 BOTTLE
    46708-025-911000 TABLET, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 46708-025-31?

    The NDC Packaged Code 46708-025-31 is assigned to a package of 100 tablet, extended release in 1 bottle of Theophylline, a human prescription drug labeled by Alembic Pharmaceuticals Limited. The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 46708-025 included in the NDC Directory?

    Yes, Theophylline with product code 46708-025 is active and included in the NDC Directory. The product was first marketed by Alembic Pharmaceuticals Limited on November 01, 2010 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 46708-025-31?

    The 11-digit format is 46708002531. 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 5-3-2 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
    5-3-246708-025-315-4-246708-0025-31