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  5. NDC Package Code: 68083-383-10 Neostigmine Methylsulfate

NDC Package 68083-383-10 Neostigmine Methylsulfate

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:
68083-383-10
Package Description:
10 CARTON in 1 CARTON / 1 VIAL, MULTI-DOSE in 1 CARTON (68083-383-01) / 10 mL in 1 VIAL, MULTI-DOSE
Product Code:
68083-383
Proprietary Name:
Neostigmine Methylsulfate
Non-Proprietary Name:
Neostigmine Methylsulfate
Substance Name:
Neostigmine Methylsulfate
Usage Information:
Neostigmine Methylsulfate Injection is a cholinesterase inhibitor indicated for the reversal of the effects of non­ depolarizing neuromuscular blocking agents after surgery.
11-Digit NDC Billing Format:
68083038310
NDC to RxNorm Crosswalk:
  • RxCUI: 311935 - neostigmine methylsulfate 0.5 MG/ML Injectable Solution
  • RxCUI: 311936 - neostigmine methylsulfate 1 MG/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):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • NEOSTIGMINE METHYLSULFATE .5 mg/mL
    • Pharmacologic Class(es):
  • Cholinesterase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Cholinesterase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA212968
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-21-2019
    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 68083-383-10?

    The NDC Packaged Code 68083-383-10 is assigned to a package of 10 carton in 1 carton / 1 vial, multi-dose in 1 carton (68083-383-01) / 10 ml in 1 vial, multi-dose of Neostigmine Methylsulfate, a human prescription drug labeled by Gland Pharma Limited. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 68083-383 included in the NDC Directory?

    Yes, Neostigmine Methylsulfate with product code 68083-383 is active and included in the NDC Directory. The product was first marketed by Gland Pharma Limited on October 21, 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 68083-383-10?

    The 11-digit format is 68083038310. 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
    5-3-268083-383-105-4-268083-0383-10