Galzin Capsule
NDC Package 57844-208-52

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

Package Information

Galzin (zinc acetate) capsules is a medication used after other medications to treat a certain liver disease (Wilson's disease). This formulation utilizes a capsule delivery system. Marketed by Teva Pharmaceuticals Usa, Inc., this product is identified by NDC 57844-208 and is authorized under FDA application NDA020458.

Identification & Billing

NDC Package Code
57844-208-52
Package Description
250 CAPSULE in 1 BOTTLE
Product Code
57844-208
11-Digit Billing Format
57844020852
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
250 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Galzin
Non-Proprietary Name
Zinc Acetate
Substance Name
Zinc Acetate
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ZINC ACETATE 50 mg/1
Pharmacologic Class
Usage Information
This medication is used after other medications to treat a certain liver disease (Wilson's disease). This inherited disease causes the liver to hold onto too much copper, resulting in liver damage and other serious problems. This medication causes the intestines to make more of a certain substance (a protein) that prevents the body from absorbing too much copper from food, thereby preventing further damage.

Regulatory & Marketing

Labeler Name
Teva Pharmaceuticals Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA020458
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-03-1997
End Marketing Date
06-30-2026
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 57844-208-52 identifies a specific commercial package of 250 capsule in 1 bottle of Galzin, a human prescription drug labeled by Teva Pharmaceuticals Usa, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 250 billable units per package. This capsule is formulated for oral use and contains zinc acetate 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 Teva Pharmaceuticals Usa, Inc. on March 03, 1997.

What are the primary indications for this medication?

This medication is used after other medications to treat a certain liver disease (Wilson's disease). This inherited disease causes the liver to hold onto too much copper, resulting in liver damage and other serious problems. This medication causes the intestines to make more of a certain substance (a protein) that prevents the body from absorbing too much copper from food, thereby preventing further damage.

How is this Teva Pharmaceuticals Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57844020852. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 250 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)
57844-208-52
11-Digit CMS (5-4-2)
57844-0208-52

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