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  5. NDC Package Code: 68083-633-01 Epinephrine

NDC Package 68083-633-01 Epinephrine

Injection Intramuscular; Intravenous; Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
68083-633-01
Package Description:
1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE
Product Code:
68083-633
Proprietary Name:
Epinephrine
Non-Proprietary Name:
Epinephrine
Substance Name:
Epinephrine
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.
11-Digit NDC Billing Format:
68083063301
NDC to RxNorm Crosswalk:
  • RxCUI: 310132 - EPINEPHrine 1 MG/ML (1:1000) Injectable Solution
  • RxCUI: 310132 - epinephrine 1 MG/ML Injectable Solution
  • RxCUI: 310132 - epinephrine (as epinephrine hydrochloride) 1 MG/ML Injectable Solution
  • RxCUI: 310132 - epinephrine 1:1000 Injectable Solution
  • RxCUI: 310132 - epinephrine 500 MCG per 0.5 ML Injectable Solution
Product Type:
Human Prescription Drug
Labeler Name:
Gland Pharma Limited
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s):
  • Intramuscular - Administration within a muscle.
  • 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(es):
Sample Package:
No
FDA Application Number:
ANDA219239
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
02-06-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 68083-633-01?

The NDC Packaged Code 68083-633-01 is assigned to a package of 1 vial, multi-dose in 1 carton / 10 ml in 1 vial, multi-dose of Epinephrine, a human prescription drug labeled by Gland Pharma Limited. The product's dosage form is injection and is administered via intramuscular; intravenous; subcutaneous form.

Is NDC 68083-633 included in the NDC Directory?

Yes, Epinephrine with product code 68083-633 is active and included in the NDC Directory. The product was first marketed by Gland Pharma Limited on February 06, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 68083-633-01?

The 11-digit format is 68083063301. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-268083-633-015-4-268083-0633-01