Epinephrine Injection Injection, Solution
NDC Package 51004-2400-1

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 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.

Epinephrine Injection injection is a medication used in emergencies to treat very serious allergic reactions to insect stings/bites, foods, drugs, or other substances. This formulation utilizes a injection, solution delivery system. Marketed by Novocol Pharmaceutical Of Canada, Inc., this product is identified by NDC 51004-2400.

Identification & Billing

NDC Package Code
51004-2400-1
Package Description
5 BAG in 1 BOX / 20 TRAY in 1 BAG / 18 CARTRIDGE in 1 TRAY / 1 mL in 1 CARTRIDGE
Product Code
51004-2400
11-Digit Billing Format
51004240001

Clinical Specifications

Proprietary Name
Epinephrine Injection
Non-Proprietary Name
Epinephrine Injection
Substance Name
Epinephrine
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Active Ingredient(s)
EPINEPHRINE 1 mg/mL
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
Novocol Pharmaceutical Of Canada, Inc.
Product Type
Drug For Further Processing
Marketing Category
EXPORT ONLY - A product that is only exported and not marketed in the United States.
Start Marketing Date
01-08-2020
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51004-2400-1 identifies a specific commercial package of 5 bag in 1 box / 20 tray in 1 bag / 18 cartridge in 1 tray / 1 ml in 1 cartridge of Epinephrine Injection (UNFINISHED drug), drug for further processing labeled by Novocol Pharmaceutical Of Canada, Inc.. This injection, solution is formulated for use and contains epinephrine 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 Novocol Pharmaceutical Of Canada, Inc. on January 08, 2020. The current certification is valid through December 31, 2026.

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 Novocol Pharmaceutical Of Canada, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51004240001. 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)
51004-2400-1
11-Digit CMS (5-4-2)
51004-2400-01

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