Galantamine Hydrobromide
NDC Package 0115-1122-03

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 discontinued by the firm.

Galantamine Hydrobromide is galantamine is used to treat mild to moderate confusion (dementia) related to Alzheimer's disease. Marketed by Impax Generics, this product is identified by NDC 0115-1122 and is authorized under FDA application ANDA078484.

Identification & Billing

NDC Package Code
0115-1122-03
Package Description
1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
0115-1122
11-Digit Billing Format
00115112203

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
Impax Generics
FDA Application #
ANDA078484
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-27-2009
End Marketing Date
03-31-2014
Listing Expiration
03-31-2014
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0115-1122). Click a package code to view its specific billing and regulatory data.

0115-1122-08
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
0115-1122-10
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 0115-1122-03 identifies a specific commercial package of 1000 capsule, extended release in 1 bottle of Galantamine Hydrobromide, labeled by Impax Generics. 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 Impax Generics on May 27, 2009. The current certification is valid through March 31, 2014.

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 Impax Generics product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00115112203. 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 (4-4-2)
0115-1122-03
11-Digit CMS (5-4-2)
00115-1122-03

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