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  5. NDC Package Code: 0904-7483-03 Roflumilast

NDC Package 0904-7483-03 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:
0904-7483-03
Package Description:
30 TABLET in 1 BOTTLE
Product Code:
0904-7483
Proprietary Name:
Roflumilast
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:
00904748303
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Major Pharmaceuticals
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 500 ug/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA208256
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
05-22-2024
Listing Expiration Date:
12-31-2026
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
0904-7483-8990 TABLET in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0904-7483-03?

The NDC Packaged Code 0904-7483-03 is assigned to a package of 30 tablet in 1 bottle of Roflumilast, a human prescription drug labeled by Major Pharmaceuticals. The product's dosage form is tablet and is administered via oral form.

Is NDC 0904-7483 included in the NDC Directory?

Yes, Roflumilast with product code 0904-7483 is active and included in the NDC Directory. The product was first marketed by Major Pharmaceuticals on May 22, 2024 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0904-7483-03?

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 30.

What is the 11-digit format for NDC 0904-7483-03?

The 11-digit format is 00904748303. 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
4-4-20904-7483-035-4-200904-7483-03