Epinephrine Injection
NDC Package 61434-040-01

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 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 delivery system. Marketed by Catalent Indiana, Llc, this product is identified by NDC 61434-040.

Identification & Billing

NDC Package Code
61434-040-01
Package Description
1280 SYRINGE in 1 CASE / 1 mL in 1 SYRINGE
Product Code
61434-040
11-Digit Billing Format
61434004001

Clinical Specifications

Proprietary Name
Epinephrine
Non-Proprietary Name
Epinephrine
Substance Name
Epinephrine
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
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
Catalent Indiana, Llc
Product Type
Human Prescription Drug
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
08-22-2018
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 61434-040-01 identifies a specific commercial package of 1280 syringe in 1 case / 1 ml in 1 syringe of Epinephrine (UNFINISHED drug), a human prescription drug labeled by Catalent Indiana, Llc. This injection 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 Catalent Indiana, Llc on August 22, 2018. 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 Catalent Indiana, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61434004001. 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)
61434-040-01
11-Digit CMS (5-4-2)
61434-0040-01

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