Glucagen
NDC Package 55390-004-01

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Glucagen is a medication the same as your body's own glucagon, a natural substance that raises blood sugar by causing the body to release sugar stored in the liver. Marketed by Bedford Laboratories, this product is identified by NDC 55390-004 and is authorized under FDA application NDA020918.

Identification & Billing

NDC Package Code
55390-004-01
Package Description
1 KIT in 1 KIT * 10 VIAL, GLASS in 1 CARTON / 1 mL in 1 VIAL, GLASS * 1 mL in 1 VIAL, GLASS
Product Code
55390-004
11-Digit Billing Format
55390000401
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Glucagen
Dosage Form
-
Usage Information
This medication is the same as your body's own glucagon, a natural substance that raises blood sugar by causing the body to release sugar stored in the liver. It is used to treat very low blood sugar (hypoglycemia) that may cause you to need help from others. To be ready ahead of time, make sure a family member or caregiver knows where you keep this medication and how to use it. Glucagon may also be used before certain X-ray procedures of the gut. It slows down movement of the stomach, intestines, and colon, which may help make the X-ray more clear.

Regulatory & Marketing

Labeler Name
Bedford Laboratories
FDA Application #
NDA020918
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-22-2005
End Marketing Date
11-30-2016
Listing Expiration
11-30-2016
Exclude Flag
D
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 (55390-004). Click a package code to view its specific billing and regulatory data.

55390-004-10
10 KIT in 1 CARTON / 1 KIT in 1 KIT * 10 VIAL, GLASS in 1 CARTON / 1 mL in 1 VIAL, GLASS * 1 mL in 1 VIAL, GLASS

* 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 55390-004-01 identifies a specific commercial package of 1 kit in 1 kit * 10 vial, glass in 1 carton / 1 ml in 1 vial, glass * 1 ml in 1 vial, glass of Glucagen, labeled by Bedford Laboratories. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Bedford Laboratories on June 22, 2005. The current certification is valid through November 30, 2016.

What are the primary indications for this medication?

This medication is the same as your body's own glucagon, a natural substance that raises blood sugar by causing the body to release sugar stored in the liver. It is used to treat very low blood sugar (hypoglycemia) that may cause you to need help from others. To be ready ahead of time, make sure a family member or caregiver knows where you keep this medication and how to use it. Glucagon may also be used before certain X-ray procedures of the gut. It slows down movement of the stomach, intestines, and colon, which may help make the X-ray more clear.

How is this Bedford Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55390000401. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
55390-004-01
11-Digit CMS (5-4-2)
55390-0004-01

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