Galantamine Hydrobromide Solution
NDC Package 0054-0137-49

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

Package Information

Galantamine Hydrobromide solution is galantamine is used to treat mild to moderate confusion (dementia) related to Alzheimer's disease. This formulation utilizes a solution delivery system. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0054-0137 and is authorized under FDA application ANDA078185.

Identification & Billing

NDC Package Code
0054-0137-49
Package Description
100 mL in 1 BOTTLE
Product Code
0054-0137
11-Digit Billing Format
00054013749
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
100 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Galantamine Hydrobromide
Non-Proprietary Name
Galantamine Hydrobromide
Substance Name
Galantamine Hydrobromide
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GALANTAMINE HYDROBROMIDE 4 mg/mL
Pharmacologic Class
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
Hikma Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA078185
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-14-2009
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0054-0137-49 identifies a specific commercial package of 100 ml in 1 bottle of Galantamine Hydrobromide, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 100 billable units per package. This solution is formulated for oral use and contains galantamine hydrobromide 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 Hikma Pharmaceuticals Usa Inc. on August 14, 2009. The current certification is valid through December 31, 2026.

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 Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00054013749. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 100 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 (4-4-2)
0054-0137-49
11-Digit CMS (5-4-2)
00054-0137-49

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