NDC Package 73377-310-03 Roflumilast

Powder - View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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:

73377-310-03

Package Description:

9.2 g in 1 JAR

Product Code:

73377-310

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:

73377031003

Product Type:

Bulk Ingredient

Labeler Name:

Ax Pharmaceutical Corp

Dosage Form:

Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

Active Ingredient(s):

ROFLUMILAST 1 g/g

Sample Package:

N/A

Marketing Category:

BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.

Start Marketing Date:

02-26-2025

Listing Expiration Date:

12-31-2026

Exclude Flag:

Unfinished Product:

Yes

Code Structure:

73377 - Ax Pharmaceutical Corp
- 73377-310 -
  - 73377-310-03 - 9.2 g in 1 JAR

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 Code	Package Description
73377-310-01	100 g in 1 JAR
73377-310-02	10 g in 1 JAR

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 73377-310-03?

The NDC Packaged Code 73377-310-03 is assigned to an UNFINISHED drug package of 9.2 g in 1 jar of Roflumilast, a bulk ingredient labeled by Ax Pharmaceutical Corp. The product's dosage form is powder and is administered via form.

Is NDC 73377-310 included in the NDC Directory?

Yes, Roflumilast is an UNFINISHED PRODUCT with code 73377-310 that is active and included in the NDC Directory. The product was first marketed by Ax Pharmaceutical Corp on February 26, 2025 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 11-digit format for NDC 73377-310-03?

The 11-digit format is 73377031003. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	73377-310-03	5-4-2	73377-0310-03

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