NDC Package 0121-0820-04 Theophylline

Solution Oral - View Billable Units, 11-Digit Format, RxNorm

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:
0121-0820-04
Package Description:
118 mL in 1 BOTTLE
Product Code:
Proprietary Name:
Theophylline
Non-Proprietary Name:
Theophylline
Substance Name:
Theophylline
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:
00121082004
NDC to RxNorm Crosswalk:
  • RxCUI: 313306 - theophylline 80 MG in 15 mL Oral Solution
  • RxCUI: 313306 - theophylline 5.33 MG/ML Oral Solution
  • RxCUI: 313306 - theophylline 100 MG per 18.75 ML Oral Solution
  • RxCUI: 313306 - theophylline 80 MG per 15 ML Oral Solution
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Pai Holdings, Llc
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA206344
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-16-2016
    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
    0121-0820-16473 mL in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0121-0820-04?

    The NDC Packaged Code 0121-0820-04 is assigned to a package of 118 ml in 1 bottle of Theophylline, a human prescription drug labeled by Pai Holdings, Llc. The product's dosage form is solution and is administered via oral form.

    Is NDC 0121-0820 included in the NDC Directory?

    Yes, Theophylline with product code 0121-0820 is active and included in the NDC Directory. The product was first marketed by Pai Holdings, Llc on December 16, 2016 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 0121-0820-04?

    The 11-digit format is 00121082004. 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 4-4-2 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
    4-4-20121-0820-045-4-200121-0820-04