Memantine Hydrochloride Capsule, Extended Release
NDC Package 65162-784-50

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

Memantine Hydrochloride capsules is memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. This formulation utilizes a capsule, extended release delivery system. Marketed by Amneal Pharmaceuticals Llc, this product is identified by NDC 65162-784 and is authorized under FDA application ANDA205825.

Identification & Billing

NDC Package Code
65162-784-50
Package Description
500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
65162-784
11-Digit Billing Format
65162078450
RxNorm Crosswalk
  • RxCUI: 996594 - memantine HCl 14 MG 24HR Extended Release Oral Capsule
  • RxCUI: 996594 - 24 HR memantine hydrochloride 14 MG Extended Release Oral Capsule
  • RxCUI: 996594 - memantine hydrochloride 14 MG 24 HR Extended Release Oral Capsule
  • RxCUI: 996603 - memantine HCl 21 MG 24HR Extended Release Oral Capsule
  • RxCUI: 996603 - 24 HR memantine hydrochloride 21 MG Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Memantine Hydrochloride
Non-Proprietary Name
Memantine Hydrochloride
Substance Name
Memantine Hydrochloride
Dosage Form
Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MEMANTINE HYDROCHLORIDE 21 mg/1
Pharmacologic Class
Usage Information
Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA205825
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-22-2017
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 (65162-784). Click a package code to view its specific billing and regulatory data.

65162-784-03
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
65162-784-09
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

* 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 65162-784-50 identifies a specific commercial package of 500 capsule, extended release in 1 bottle of Memantine Hydrochloride, a human prescription drug labeled by Amneal Pharmaceuticals Llc. This capsule, extended release is formulated for oral use and contains memantine hydrochloride 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 Amneal Pharmaceuticals Llc on December 22, 2017. The current certification is valid through December 31, 2026.

How is this Amneal Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65162078450. 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 (5-3-2)
65162-784-50
11-Digit CMS (5-4-2)
65162-0784-50

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