NDC Package 57841-1301-2 Movantik

Naloxegol Oxalate Tablet, Film Coated Oral - 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:
57841-1301-2
Package Description:
90 TABLET, FILM COATED in 1 BOTTLE
Product Code:
Proprietary Name:
Movantik
Non-Proprietary Name:
Naloxegol Oxalate
Substance Name:
Naloxegol Oxalate
Usage Information:
This medication is used to treat constipation caused by opioid medications in people with ongoing pain that is not caused by cancer. It blocks the effect of opioids on the gut without blocking the effect on pain. Naloxegol belongs to a class of drugs known as opioid antagonists.
11-Digit NDC Billing Format:
57841130102
NDC to RxNorm Crosswalk:
  • RxCUI: 1551782 - naloxegol 25 MG Oral Tablet
  • RxCUI: 1551782 - naloxegol 25 MG (as naloxegol oxalate 28.5 MG) Oral Tablet
  • RxCUI: 1551917 - naloxegol 12.5 MG Oral Tablet
  • RxCUI: 1551917 - naloxegol 12.5 MG (as naloxegol oxalate 14.2 MG) Oral Tablet
  • RxCUI: 1551923 - movantik 12.5 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Redhill Biopharma Ltd
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    NDA204760
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    10-01-2020
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    57841-1301-130 TABLET, FILM COATED in 1 BOTTLE
    57841-1301-310 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK
    57841-1301-41 BLISTER PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 57841-1301-2?

    The NDC Packaged Code 57841-1301-2 is assigned to a package of 90 tablet, film coated in 1 bottle of Movantik, a human prescription drug labeled by Redhill Biopharma Ltd. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 57841-1301 included in the NDC Directory?

    Yes, Movantik with product code 57841-1301 is active and included in the NDC Directory. The product was first marketed by Redhill Biopharma Ltd on October 01, 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 57841-1301-2?

    The 11-digit format is 57841130102. 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 5-4-1 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
    5-4-157841-1301-25-4-257841-1301-02