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  5. NDC Package Code: 68083-452-10 Esomeprazole Sodium

NDC Package 68083-452-10 Esomeprazole Sodium

Injection Intravenous - 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:
68083-452-10
Package Description:
10 VIAL in 1 CARTON / 5 mL in 1 VIAL (68083-452-01)
Product Code:
68083-452
Proprietary Name:
Esomeprazole Sodium
Non-Proprietary Name:
Esomeprazole Sodium
Substance Name:
Esomeprazole Sodium
Usage Information:
• Esomeprazole sodium is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [see Adverse Reactions (6.2)]. • Proton pump inhibitors (PPIs), including esomeprazole sodium for injection are contraindicated in patients receiving rilpivirine¬ containing products [see Drug Interactions (7)].
11-Digit NDC Billing Format:
68083045210
NDC to RxNorm Crosswalk:
  • RxCUI: 486499 - esomeprazole 20 MG Injection
  • RxCUI: 486499 - esomeprazole 20 MG (as esomeprazole sodium 21.3 MG) Injection
  • RxCUI: 486501 - esomeprazole 40 MG Injection
  • RxCUI: 486501 - esomeprazole 40 MG (as esomeprazole sodium 42.5 MG) Injection
    • 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):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • ESOMEPRAZOLE SODIUM 40 mg/5mL
    • Pharmacologic Class(es):
  • Cytochrome P450 2C19 Inhibitors - [MoA] (Mechanism of Action)
  • Proton Pump Inhibitor - [EPC] (Established Pharmacologic Class)
  • Proton Pump Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA203349
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-01-2020
    Listing Expiration Date:
    12-31-2024
    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 68083-452-10?

    The NDC Packaged Code 68083-452-10 is assigned to a package of 10 vial in 1 carton / 5 ml in 1 vial (68083-452-01) of Esomeprazole Sodium, a human prescription drug labeled by Gland Pharma Limited. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 68083-452 included in the NDC Directory?

    Yes, Esomeprazole Sodium with product code 68083-452 is active and included in the NDC Directory. The product was first marketed by Gland Pharma Limited on April 01, 2020 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 68083-452-10?

    The 11-digit format is 68083045210. 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
    5-3-268083-452-105-4-268083-0452-10