Epinephrine
NDC Package 54868-5725-0

11-digit billing NDC: 54868572500 · Billing unit: ML · 100 ML per package
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.

Epinephrine is injection, USP is indicated for intravenous injection in (1) treatment of acute hypersensitivity (anaphylactoid reactions to drugs, animal serums and other allergens), (2) treatment of acute asthmatic attacks to relieve bronchospasm not controlled by inhalation or subcutaneous administration of other solutions of the drug and (3) treatment and prophylaxis of cardiac arrest and attacks of transitory atrioventricular (A-V) heart block with syncopal seizures (Stokes-Adams Syndrome).In acute attacks of ventricular standstill, physical measures should be applied first. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5725 and is authorized under FDA application NDA020800.

Identification & Billing

NDC Package Code
54868-5725-0
Package Description
10 POUCH in 1 BOX / 1 SYRINGE, GLASS in 1 POUCH / 10 mL in 1 SYRINGE, GLASS
Product Code
54868-5725
11-Digit Billing Format
54868572500
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
100 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Epinephrine
Dosage Form
-
Usage Information
Epinephrine Injection, USP is indicated for intravenous injection in (1) treatment of acute hypersensitivity (anaphylactoid reactions to drugs, animal serums and other allergens), (2) treatment of acute asthmatic attacks to relieve bronchospasm not controlled by inhalation or subcutaneous administration of other solutions of the drug and (3) treatment and prophylaxis of cardiac arrest and attacks of transitory atrioventricular (A-V) heart block with syncopal seizures (Stokes-Adams Syndrome).In acute attacks of ventricular standstill, physical measures should be applied first. When external cardiac compression and attempts to restore the circulation by electrical defibrillation or use of a pacemaker fail, intracardiac puncture and intramyocardial injection of epinephrine may be effective.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA020800
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-11-2006
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 54868-5725-0 identifies a specific commercial package of 10 pouch in 1 box / 1 syringe, glass in 1 pouch / 10 ml in 1 syringe, glass of Epinephrine, labeled by Physicians Total Care, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 100 billable units per package. 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 December 11, 2006. 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: 54868572500. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 100 total billable units per package. 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)
54868-5725-0
11-Digit CMS (5-4-2)
54868-5725-00

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