1. Home
  2. Labeler Index
  3. Amneal Pharmaceuticals Llc
  4. 65162-553
  5. NDC Package Code: 65162-553-50 Metaxalone

NDC Package 65162-553-50 Metaxalone

Tablet 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:
65162-553-50
Package Description:
500 TABLET in 1 BOTTLE
Product Code:
65162-553
Proprietary Name:
Metaxalone
Non-Proprietary Name:
Metaxalone
Substance Name:
Metaxalone
Usage Information:
Metaxalone is used to treat muscle spasms/pain. It is usually used along with rest, physical therapy, and other treatment.
11-Digit NDC Billing Format:
65162055350
NDC to RxNorm Crosswalk:
  • RxCUI: 351254 - metaxalone 800 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amneal Pharmaceuticals Llc
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • METAXALONE 800 mg/1
    • Pharmacologic Class(es):
  • Centrally-mediated Muscle Relaxation - [PE] (Physiologic Effect)
  • Muscle Relaxant - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA203399
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-31-2013
    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
    65162-553-10100 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65162-553-50?

    The NDC Packaged Code 65162-553-50 is assigned to a package of 500 tablet in 1 bottle of Metaxalone, a human prescription drug labeled by Amneal Pharmaceuticals Llc. The product's dosage form is tablet and is administered via oral form.

    Is NDC 65162-553 included in the NDC Directory?

    Yes, Metaxalone with product code 65162-553 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Llc on May 31, 2013 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 65162-553-50?

    The 11-digit format is 65162055350. 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
    5-3-265162-553-505-4-265162-0553-50