Glucagon
NDC Package 54868-5070-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Glucagon is severe hypoglycemia should be treated initially with intravenous glucose, if possible.If parenteral glucose can not be used, dissolve the lyophilized glucagon using the accompanying diluting solution and use immediately.For adults and for pediatric patients weighing more than 44 lb (20 kg), give 1 mg (1 unit) by subcutaneous, intramuscular, or intravenous injection.For pediatric patients weighing less than 44 lb (20 kg), give 0.5 mg (0.5 unit) or a dose equivalent to 20 to 30 μg/kg.2-6Discard any unused portion.An unconscious patient will usually awaken within 15 minutes following the glucagon injection. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5070 and is authorized under FDA application NDA020928.

Identification & Billing

NDC Package Code
54868-5070-0
Package Description
1 KIT in 1 KIT * 1 mL in 1 SYRINGE * 1 mL in 1 VIAL
Product Code
54868-5070
11-Digit Billing Format
54868507000
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk
RxCUI: 310497 - glucagon (rDNA) 1 MG Injection

Clinical Specifications

Proprietary Name
Glucagon
Dosage Form
-
Usage Information
Severe hypoglycemia should be treated initially with intravenous glucose, if possible.If parenteral glucose can not be used, dissolve the lyophilized glucagon using the accompanying diluting solution and use immediately.For adults and for pediatric patients weighing more than 44 lb (20 kg), give 1 mg (1 unit) by subcutaneous, intramuscular, or intravenous injection.For pediatric patients weighing less than 44 lb (20 kg), give 0.5 mg (0.5 unit) or a dose equivalent to 20 to 30 μg/kg.2-6Discard any unused portion.An unconscious patient will usually awaken within 15 minutes following the glucagon injection. If the response is delayed, there is no contraindication to the administration of an additional dose of glucagon; however, in view of the deleterious effects of cerebral hypoglycemia emergency aid should be sought so that parenteral glucose can be given.After the patient responds, supplemental carbohydrate should be given to restore liver glycogen and to prevent secondary hypoglycemia.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA020928
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-24-2004
Listing Expiration
12-31-2017
Exclude Flag
I
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54868-5070-0 identifies a specific commercial package of 1 kit in 1 kit * 1 ml in 1 syringe * 1 ml in 1 vial of Glucagon, labeled by Physicians Total Care, Inc.. 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 Physicians Total Care, Inc. on May 24, 2004. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868507000. 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 (5-4-1)
54868-5070-0
11-Digit CMS (5-4-2)
54868-5070-00

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