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  5. NDC Package Code: 0310-0088-39 Daliresp

NDC Package 0310-0088-39 Daliresp

Roflumilast Tablet 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:
0310-0088-39
Package Description:
10 BLISTER PACK in 1 BOX, UNIT-DOSE / 2 TABLET in 1 BLISTER PACK
Product Code:
0310-0088
Proprietary Name:
Daliresp
Non-Proprietary Name:
Roflumilast
Substance Name:
Roflumilast
Usage Information:
Roflumilast is used to control and prevent symptoms (wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis). It should be used along with other medications (bronchodilators such as salmeterol, ipratropium) to treat COPD. It works by reducing the irritation and swelling of the airways. 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 shortness of breath or wheezing. If sudden breathing problems occur, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.
11-Digit NDC Billing Format:
00310008839
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
10 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1091839 - roflumilast 500 MCG Oral Tablet
  • RxCUI: 1091839 - roflumilast 0.5 MG Oral Tablet
  • RxCUI: 1091843 - Daliresp 500 MCG Oral Tablet
  • RxCUI: 1091843 - roflumilast 0.5 MG Oral Tablet [Daliresp]
  • RxCUI: 1091843 - Daliresp 0.5 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Astrazeneca Pharmaceuticals Lp
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ROFLUMILAST 250 ug/1
    • Pharmacologic Class(es):
  • Phosphodiesterase 4 Inhibitor - [EPC] (Established Pharmacologic Class)
  • Phosphodiesterase 4 Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA022522
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    07-01-2015
    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
    0310-0088-281 BLISTER PACK in 1 BOX, UNIT-DOSE / 28 TABLET in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0310-0088-39?

    The NDC Packaged Code 0310-0088-39 is assigned to a package of 10 blister pack in 1 box, unit-dose / 2 tablet in 1 blister pack of Daliresp, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. The product's dosage form is tablet and is administered via oral form.

    Is NDC 0310-0088 included in the NDC Directory?

    Yes, Daliresp with product code 0310-0088 is active and included in the NDC Directory. The product was first marketed by Astrazeneca Pharmaceuticals Lp on July 01, 2015 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 NDC billing unit for package 0310-0088-39?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 10.

    What is the 11-digit format for NDC 0310-0088-39?

    The 11-digit format is 00310008839. 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
    4-4-20310-0088-395-4-200310-0088-39