Epinephrine Injection, Solution, Concentrate
NDC Package 68083-591-10

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

Package Information

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, solution, concentrate delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-591 and is authorized under FDA application ANDA218144.

Identification & Billing

NDC Package Code
68083-591-10
Package Description
10 AMPULE in 1 BOX / 1 mL in 1 AMPULE
Product Code
68083-591
11-Digit Billing Format
68083059110
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Epinephrine
Non-Proprietary Name
Epinephrine
Substance Name
Epinephrine
Dosage Form
Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intraocular - Administration within the eye.
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
EPINEPHRINE 1 mg/mL
Pharmacologic Class
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
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA218144
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-03-2025
Listing Expiration
12-31-2026
Exclude Flag
N
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 68083-591-10 identifies a specific commercial package of 10 ampule in 1 box / 1 ml in 1 ampule of Epinephrine, a human prescription drug labeled by Gland Pharma Limited. This injection, solution, concentrate is formulated for intramuscular; intraocular; intravenous; subcutaneous 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 Gland Pharma Limited on June 03, 2025. 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 Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083059110. 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)
68083-591-10
11-Digit CMS (5-4-2)
68083-0591-10

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