Roflumilast Tablet
NDC Package 72205-201-30

11-digit billing NDC: 72205020130
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Roflumilast tablets is  are indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.Limitations of Use Roflumilast Tablets are not a bronchodilator and is not indicated for the relief of acute bronchospasm. This formulation utilizes a tablet delivery system. Marketed by Novadoz Pharmaceuticals Llc, this product is identified by NDC 72205-201 and is authorized under FDA application ANDA208256.

Identification & Billing

NDC Package Code
72205-201-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
72205-201
11-Digit Billing Format
72205020130
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Roflumilast
Non-Proprietary Name
Roflumilast
Substance Name
Roflumilast
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ROFLUMILAST 250 ug/1
Pharmacologic Class
Usage Information
Roflumilast Tablets are indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.Limitations of Use Roflumilast Tablets are not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast Tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.

Regulatory & Marketing

Labeler Name
Novadoz Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA208256
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-07-2022
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (72205-201). Click a package code to view its specific billing and regulatory data.

72205-201-24
2 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK (72205-201-11)
72205-201-32
2 BLISTER PACK in 1 CARTON / 14 TABLET in 1 BLISTER PACK (72205-201-13)

* 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 72205-201-30 identifies a specific commercial package of 30 tablet in 1 bottle of Roflumilast, a human prescription drug labeled by Novadoz Pharmaceuticals Llc. This tablet is formulated for oral use and contains roflumilast 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 Novadoz Pharmaceuticals Llc on September 07, 2022. The current certification is valid through December 31, 2027.

How is this Novadoz Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72205020130. 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 (5-3-2)
72205-201-30
11-Digit CMS (5-4-2)
72205-0201-30

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