Galantamine Hydrobromide
NDC Package 51990-113-04

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.

Galantamine Hydrobromide is galantamine is used to treat mild to moderate confusion (dementia) related to Alzheimer's disease. Marketed by Yabao Pharmaceutical Co., Ltd. Beijing, this product is identified by NDC 51990-113 and is authorized under FDA application NDA021169.

Identification & Billing

NDC Package Code
51990-113-04
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
51990-113
11-Digit Billing Format
51990011304
RxNorm Crosswalk

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
Yabao Pharmaceutical Co., Ltd. Beijing
FDA Application #
NDA021169
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-01-2001
Listing Expiration
12-31-2017
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 (51990-113). Click a package code to view its specific billing and regulatory data.

51990-113-02
100 TABLET, FILM COATED in 1 BOTTLE
51990-113-03
1000 TABLET, FILM COATED 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 51990-113-04 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Galantamine Hydrobromide, labeled by Yabao Pharmaceutical Co., Ltd. Beijing. 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 Yabao Pharmaceutical Co., Ltd. Beijing on March 01, 2001. The current certification is valid through December 31, 2017.

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 Yabao Pharmaceutical Co., Ltd. Beijing product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51990011304. 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)
51990-113-04
11-Digit CMS (5-4-2)
51990-0113-04

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