Galantamine Hydrobromide
NDC Package 43353-984-05

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Galantamine Hydrobromide is galantamine is used to treat mild to moderate confusion (dementia) related to Alzheimer's disease. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 43353-984 and is authorized under FDA application ANDA079028.

Identification & Billing

NDC Package Code
43353-984-05
Package Description
4200 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
43353-984
11-Digit Billing Format
43353098405
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4200 EA

Clinical Specifications

Proprietary Name
Galantamine Hydrobromide
Dosage Form
-
Usage Information
Galantamine is used to treat mild to moderate confusion (dementia) related to Alzheimer's disease. It does not cure Alzheimer's disease, but it may improve memory, awareness, and the ability to perform daily functions. This medication works by restoring the balance of certain natural substances (neurotransmitters) in the brain.

Regulatory & Marketing

Labeler Name
Aphena Pharma Solutions - Tennessee, Llc
FDA Application #
ANDA079028
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-15-2009
End Marketing Date
11-30-2015
Listing Expiration
11-30-2015
Exclude Flag
D
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 43353-984-05 identifies a specific commercial package of 4200 capsule, extended release in 1 bottle of Galantamine Hydrobromide, labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 4200 billable units per package. 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 Aphena Pharma Solutions - Tennessee, Llc on December 15, 2009. The current certification is valid through November 30, 2015.

What are the primary indications for this medication?

Galantamine is used to treat mild to moderate confusion (dementia) related to Alzheimer's disease. It does not cure Alzheimer's disease, but it may improve memory, awareness, and the ability to perform daily functions. This medication works by restoring the balance of certain natural substances (neurotransmitters) in the brain.

How is this Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43353098405. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 4200 total billable units per package. 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)
43353-984-05
11-Digit CMS (5-4-2)
43353-0984-05

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