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  5. NDC Package Code: 52605-071-10 Memantine Hydrochloride

NDC Package 52605-071-10 Memantine Hydrochloride

Tablet, Film Coated 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:
52605-071-10
Package Description:
1000 TABLET, FILM COATED in 1 BOTTLE
Product Code:
52605-071
Proprietary Name:
Memantine Hydrochloride
Non-Proprietary Name:
Memantine Hydrochloride
Substance Name:
Memantine Hydrochloride
Usage Information:
Memantine hydrochloride tablets, USP are an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
11-Digit NDC Billing Format:
52605007110
NDC to RxNorm Crosswalk:
  • RxCUI: 996561 - memantine HCl 10 MG Oral Tablet
  • RxCUI: 996561 - memantine hydrochloride 10 MG Oral Tablet
  • RxCUI: 996571 - memantine HCl 5 MG Oral Tablet
  • RxCUI: 996571 - memantine hydrochloride 5 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Polygen Pharmaceuticals Inc.
    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):
  • MEMANTINE HYDROCHLORIDE 5 mg/1
    • Pharmacologic Class(es):
  • N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA210587
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-01-2021
    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
    52605-071-1330 TABLET, FILM COATED in 1 BOTTLE
    52605-071-1660 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 52605-071-10?

    The NDC Packaged Code 52605-071-10 is assigned to a package of 1000 tablet, film coated in 1 bottle of Memantine Hydrochloride, a human prescription drug labeled by Polygen Pharmaceuticals Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 52605-071 included in the NDC Directory?

    Yes, Memantine Hydrochloride with product code 52605-071 is active and included in the NDC Directory. The product was first marketed by Polygen Pharmaceuticals Inc. on July 01, 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 52605-071-10?

    The 11-digit format is 52605007110. 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
    5-3-252605-071-105-4-252605-0071-10