Epinephrine
NDC Package 54505-101-01

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.

Epinephrine is a medication used in emergencies to treat very serious allergic reactions to insect stings/bites, foods, drugs, or other substances. Marketed by Lineage Therapeutics Inc, this product is identified by NDC 54505-101 and is authorized under FDA application NDA020800.

Identification & Billing

NDC Package Code
54505-101-01
Package Description
1 CASE in 1 CARTON / 1 SYRINGE, GLASS in 1 CASE / .15 mL in 1 SYRINGE, GLASS
Product Code
54505-101
11-Digit Billing Format
54505010101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Epinephrine
Dosage Form
-
Usage Information
This medication is used in emergencies to treat very serious allergic reactions to insect stings/bites, foods, drugs, or other substances. Epinephrine acts quickly to improve breathing, stimulate the heart, raise a dropping blood pressure, reverse hives, and reduce swelling of the face, lips, and throat.

Regulatory & Marketing

Labeler Name
Lineage Therapeutics Inc
FDA Application #
NDA020800
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
04-01-2010
End Marketing Date
04-30-2018
Listing Expiration
04-30-2018
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 (54505-101). Click a package code to view its specific billing and regulatory data.

54505-101-02
2 CASE in 1 CARTON / 1 SYRINGE, GLASS in 1 CASE / .15 mL in 1 SYRINGE, 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 54505-101-01 identifies a specific commercial package of 1 case in 1 carton / 1 syringe, glass in 1 case / .15 ml in 1 syringe, glass of Epinephrine, labeled by Lineage Therapeutics 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 Lineage Therapeutics Inc on April 01, 2010. The current certification is valid through April 30, 2018.

What are the primary indications for this medication?

This medication is used in emergencies to treat very serious allergic reactions to insect stings/bites, foods, drugs, or other substances. Epinephrine acts quickly to improve breathing, stimulate the heart, raise a dropping blood pressure, reverse hives, and reduce swelling of the face, lips, and throat.

How is this Lineage Therapeutics Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54505010101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-3-2)
54505-101-01
11-Digit CMS (5-4-2)
54505-0101-01

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