NDC Package 68083-211-25 Esmolol Hydrochloride

Injection Intravenous - View Billable Units, 11-Digit Format, RxNorm

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:
68083-211-25
Package Description:
25 VIAL in 1 CARTON / 10 mL in 1 VIAL (68083-211-01)
Product Code:
Proprietary Name:
Esmolol Hydrochloride
Non-Proprietary Name:
Esmolol Hydrochloride
Substance Name:
Esmolol Hydrochloride
Usage Information:
Esmolol hydrochloride injection is available in a ready-to-use vial. Esmolol hydrochloride injection is not compatible with Sodium Bicarbonate (5%) solution (limited stability) or furosemide (precipitation). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.Ready-to-Use VialThe Ready-to-use Vial may be used to administer a loading dosage by hand-held syringe while the maintenance infusion is being prepared [see How Supplied/Storage and Handling (16.2)]. Compatibility with Commonly Used Intravenous FluidsEsmolol hydrochloride injection was tested for compatibility with ten commonly used intravenous fluids at a final concentration of 10 mg Esmolol Hydrochloride per mL. Esmolol hydrochloride injection was found to be compatible with the following solutions and was stable for at least 24 hours at controlled room temperature or under refrigeration: Dextrose (5%) Injection, USPDextrose (5%) in Lactated Ringer's Injection Dextrose (5%) in Ringer's InjectionDextrose (5%) and Sodium Chloride (0.45%) Injection, USPDextrose (5%) and Sodium Chloride (0.9%) Injection, USPLactated Ringer's Injection, USPPotassium Chloride (40 mEq/liter) in Dextrose (5%) Injection, USPSodium Chloride (0.45%) Injection, USPSodium Chloride (0.9%) Injection, USP
11-Digit NDC Billing Format:
68083021125
NDC to RxNorm Crosswalk:
  • RxCUI: 1736546 - esmolol HCl 100 MG in 10 ML Injection
  • RxCUI: 1736546 - 10 ML esmolol hydrochloride 10 MG/ML Injection
  • RxCUI: 1736546 - esmolol HCl 100 MG per 10 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):
    Sample Package:
    No
    FDA Application Number:
    ANDA208538
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-19-2019
    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 68083-211-25?

    The NDC Packaged Code 68083-211-25 is assigned to a package of 25 vial in 1 carton / 10 ml in 1 vial (68083-211-01) of Esmolol 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 68083-211 included in the NDC Directory?

    Yes, Esmolol Hydrochloride with product code 68083-211 is active and included in the NDC Directory. The product was first marketed by Gland Pharma Limited on August 19, 2019 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 68083-211-25?

    The 11-digit format is 68083021125. 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
    5-3-268083-211-255-4-268083-0211-25