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  5. NDC Package Code: 68083-238-20 Dexmedetomidine Hydrochloride

NDC Package 68083-238-20 Dexmedetomidine Hydrochloride

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:
68083-238-20
Package Description:
20 VIAL in 1 CARTON / 50 mL in 1 VIAL (68083-238-01)
Product Code:
68083-238
Proprietary Name:
Dexmedetomidine Hydrochloride
Non-Proprietary Name:
Dexmedetomidine Hydrochloride
Substance Name:
Dexmedetomidine Hydrochloride
Usage Information:
None.
11-Digit NDC Billing Format:
68083023820
NDC to RxNorm Crosswalk:
  • RxCUI: 1718906 - dexmedeTOMIDine HCl 200 MCG in 50 ML Injection
  • RxCUI: 1718906 - 50 ML dexmedetomidine 0.004 MG/ML Injection
  • RxCUI: 1718906 - dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML Injection
  • RxCUI: 1718909 - dexmedeTOMIDine HCl 400 MCG in 100 ML Injection
  • RxCUI: 1718909 - 100 ML dexmedetomidine 0.004 MG/ML 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):
  • DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL
    • Pharmacologic Class(es):
  • Adrenergic alpha2-Agonists - [MoA] (Mechanism of Action)
  • Central alpha-2 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
  • General Anesthesia - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    ANDA209307
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-03-2020
    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 68083-238-20?

    The NDC Packaged Code 68083-238-20 is assigned to a package of 20 vial in 1 carton / 50 ml in 1 vial (68083-238-01) of Dexmedetomidine Hydrochloride, a human prescription drug labeled by Gland Pharma Limited. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 68083-238 included in the NDC Directory?

    Yes, Dexmedetomidine Hydrochloride with product code 68083-238 is active and included in the NDC Directory. The product was first marketed by Gland Pharma Limited on June 03, 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 68083-238-20?

    The 11-digit format is 68083023820. 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
    5-3-268083-238-205-4-268083-0238-20