NDC Package 68083-376-25 Glycopyrrolate

Injection Intramuscular; 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:
68083-376-25
Package Description:
25 VIAL in 1 CARTON / 1 mL in 1 VIAL (68083-376-01)
Product Code:
Proprietary Name:
Glycopyrrolate
Non-Proprietary Name:
Glycopyrrolate
Substance Name:
Glycopyrrolate
Usage Information:
Glycopyrrolate is used with other drugs to treat a certain type of stomach/intestinal ulcer (peptic ulcer). This medication may help relieve stomach/abdominal pain. However, it has not been shown to be effective in healing these ulcers, preventing them from returning, or preventing other problems caused by ulcers. Glycopyrrolate works by decreasing the amount of acid in the stomach. It also slows the natural movements of the gut and relaxes the muscles in the stomach/intestines. Glycopyrrolate belongs to a class of drugs known as anticholinergics.
11-Digit NDC Billing Format:
68083037625
NDC to RxNorm Crosswalk:
  • RxCUI: 1731582 - glycopyrrolate 0.2 MG in 1 ML Injection
  • RxCUI: 1731582 - 1 ML glycopyrrolate 0.2 MG/ML Injection
  • RxCUI: 1731582 - glycopyrrolate 0.2 MG per 1 ML Injection
  • RxCUI: 1731590 - glycopyrrolate 0.4 MG in 2 ML Injection
  • RxCUI: 1731590 - 2 ML glycopyrrolate 0.2 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):
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA212612
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-09-2019
    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.

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    Frequently Asked Questions

    What is NDC 68083-376-25?

    The NDC Packaged Code 68083-376-25 is assigned to a package of 25 vial in 1 carton / 1 ml in 1 vial (68083-376-01) of Glycopyrrolate, a human prescription drug labeled by Gland Pharma Limited. The product's dosage form is injection and is administered via intramuscular; intravenous form.

    Is NDC 68083-376 included in the NDC Directory?

    Yes, Glycopyrrolate with product code 68083-376 is active and included in the NDC Directory. The product was first marketed by Gland Pharma Limited on October 09, 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 68083-376-25?

    The 11-digit format is 68083037625. 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
    5-3-268083-376-255-4-268083-0376-25