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  5. NDC Package Code: 65162-842-18 Lubiprostone

NDC Package 65162-842-18 Lubiprostone

Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
65162-842-18
Package Description:
180 CAPSULE in 1 BOTTLE
Product Code:
65162-842
Proprietary Name:
Lubiprostone
Non-Proprietary Name:
Lubiprostone
Substance Name:
Lubiprostone
Usage Information:
This medication is used to treat certain types of constipation (chronic idiopathic constipation, irritable bowel syndrome with constipation). Chronic idiopathic constipation has an unknown cause and is not due to diet, other diseases, or drugs. Lubiprostone is also used to treat constipation caused by opioid medications in people with ongoing pain due to medical conditions other than cancer. This medication may improve symptoms such as bloating and abdominal discomfort, improve stool texture, lessen the need to strain, and decrease the feeling of not completely relieving oneself. Lubiprostone belongs to a class of drugs known as chloride channel activators. It works by increasing the amount of fluid within your intestines, making the passage of stool easier.
11-Digit NDC Billing Format:
65162084218
NDC to RxNorm Crosswalk:
  • RxCUI: 616578 - lubiprostone 24 MCG Oral Capsule
  • RxCUI: 616578 - lubiprostone 0.024 MG Oral Capsule
  • RxCUI: 794639 - lubiprostone 8 MCG Oral Capsule
  • RxCUI: 794639 - lubiprostone 0.008 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amneal Pharmaceuticals Llc
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • LUBIPROSTONE 24 ug/1
    • Pharmacologic Class(es):
  • Chloride Channel Activator - [EPC] (Established Pharmacologic Class)
  • Chloride Channel Activators - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA209450
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-03-2021
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    65162-842-0660 CAPSULE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65162-842-18?

    The NDC Packaged Code 65162-842-18 is assigned to a package of 180 capsule in 1 bottle of Lubiprostone, a human prescription drug labeled by Amneal Pharmaceuticals Llc. The product's dosage form is capsule and is administered via oral form.

    Is NDC 65162-842 included in the NDC Directory?

    Yes, Lubiprostone with product code 65162-842 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Llc on December 03, 2021 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 65162-842-18?

    The 11-digit format is 65162084218. 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
    5-3-265162-842-185-4-265162-0842-18