Budesonide, Glycopyrrolate And Formoterol Fumarate Aerosol, Metered
NDC Package 12516-4616-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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.

Budesonide, Glycopyrrolate And Formoterol Fumarate aerosols is a drug for further processing. This formulation utilizes a aerosol, metered delivery system. Marketed by Bespak Hc Limited, this product is identified by NDC 12516-4616.

Identification & Billing

NDC Package Code
12516-4616-2
Package Description
320 POUCH in 1 BOX / 160 INHALER in 1 POUCH / 28 AEROSOL, METERED in 1 INHALER
Product Code
12516-4616
11-Digit Billing Format
12516461602

Clinical Specifications

Proprietary Name
Budesonide, Glycopyrrolate And Formoterol Fumarate
Non-Proprietary Name
Budesonide, Glycopyrrolate And Formoterol Fumarate
Substance Name
Budesonide; Formoterol Fumarate; Glycopyrrolate
Dosage Form
Aerosol, Metered - A pressurized dosage form consisting of metered dose valves which allow for the delivery of a uniform quantity of spray upon each activation.
Active Ingredient(s)

Regulatory & Marketing

Labeler Name
Bespak Hc Limited
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
07-23-2020
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (12516-4616). Click a package code to view its specific billing and regulatory data.

12516-4616-1
320 POUCH in 1 BOX / 160 INHALER in 1 POUCH / 120 AEROSOL, METERED in 1 INHALER
12516-4616-3
320 POUCH in 1 BOX / 160 INHALER in 1 POUCH / 28 AEROSOL, METERED in 1 INHALER

* 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 12516-4616-2 identifies a specific commercial package of 320 pouch in 1 box / 160 inhaler in 1 pouch / 28 aerosol, metered in 1 inhaler of Budesonide, Glycopyrrolate And Formoterol Fumarate (UNFINISHED drug), drug for further processing labeled by Bespak Hc Limited. This aerosol, metered is formulated for use and contains budesonide; formoterol fumarate; glycopyrrolate 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 Bespak Hc Limited on July 23, 2020. The current certification is valid through December 31, 2027.

How is this Bespak Hc Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12516461602. 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 (5-4-1)
12516-4616-2
11-Digit CMS (5-4-2)
12516-4616-02

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