Memantine Hydrochloride
NDC Package 47335-034-83

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Memantine Hydrochloride is extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 47335-034 and is authorized under FDA application ANDA205905.

Identification & Billing

NDC Package Code
47335-034-83
Package Description
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
47335-034
11-Digit Billing Format
47335003483
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
Dosage Form
-
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
Sun Pharmaceutical Industries, Inc.
FDA Application #
ANDA205905
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-14-2013
Listing Expiration
12-31-2024
Exclude Flag
I
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 (47335-034). Click a package code to view its specific billing and regulatory data.

47335-034-18
1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
47335-034-81
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 47335-034-83 identifies a specific commercial package of 30 capsule, extended release in 1 bottle of Memantine Hydrochloride, labeled by Sun Pharmaceutical Industries, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Sun Pharmaceutical Industries, Inc. on June 14, 2013. The current certification is valid through December 31, 2024.

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47335003483. 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)
47335-034-83
11-Digit CMS (5-4-2)
47335-0034-83

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