Movantik Tablet, Film Coated
NDC Package 82625-8802-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Movantik (naloxegol oxalate) tablets is a medication used to treat constipation caused by opioid medications in people with ongoing pain that is not caused by cancer. This formulation utilizes a tablet, film coated delivery system. Marketed by Valinor Pharma, Llc, this product is identified by NDC 82625-8802 and is authorized under FDA application NDA204760.

Identification & Billing

NDC Package Code
82625-8802-2
Package Description
90 TABLET, FILM COATED in 1 BOTTLE
Product Code
82625-8802
11-Digit Billing Format
82625880202
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Movantik
Non-Proprietary Name
Naloxegol Oxalate
Substance Name
Naloxegol Oxalate
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NALOXEGOL OXALATE 25 mg/1
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Valinor Pharma, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA204760
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-28-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (82625-8802). Click a package code to view its specific billing and regulatory data.

82625-8802-1
30 TABLET, FILM COATED in 1 BOTTLE
82625-8802-3
10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK
82625-8802-4
1 BLISTER PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 BLISTER PACK

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 82625-8802-2 identifies a specific commercial package of 90 tablet, film coated in 1 bottle of Movantik, a human prescription drug labeled by Valinor Pharma, Llc. This tablet, film coated is formulated for oral use and contains naloxegol oxalate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Valinor Pharma, Llc on March 28, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Valinor Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82625880202. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
82625-8802-2
11-Digit CMS (5-4-2)
82625-8802-02

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.