Galzin Capsule, Gelatin Coated
NDC 71863-124

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 71863-124?
  5. Galzin Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Galzin (zinc acetate) is a NDA-approved product labeled by Eton Pharmaceuticals, Inc.. This medication is used after other medications to treat a certain liver disease (Wilson's disease). It is supplied as a blue capsule, gelatin coated for oral administration. This product entry covers the primary NDC 71863-124 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
71863-124
Proprietary Name:
Galzin
Non-Proprietary Name: [1]
Zinc Acetate
Substance Name: [2]
Zinc Acetate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Eton Pharmaceuticals, Inc.
Labeler Code:
71863
Product Label ID:
2c4fb943-4b2f-273d-e063-6394a90abb47
FDA Application Number: [6]
NDA020458
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
03-03-2025
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
BLUE (C48333 - (AQUA BLUE))
Shape:
CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
93;215;93;215

Code Structure Chart

Product Details

What is NDC 71863-124?

The NDC code 71863-124 is assigned by the FDA to the product Galzin. It is commonly known by its generic name, zinc acetate. This pharmaceutical product is labeled by Eton Pharmaceuticals, Inc. and is currently categorized as listed product. The medication is a capsule, gelatin coated administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 71863-124-25. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ZINC ACETATE 25 mg/1 - A salt produced by the reaction of zinc oxide with acetic acid and used as an astringent, styptic, and emetic.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the full disclaimer at the bottom of this page.

Patient Education

Zinc


What is it? Zinc is an essential trace element commonly found in red meat, poultry, and fish. It is necessary in small amounts for human health, growth, and sense of taste.

Zinc is found throughout the body. The body doesn't store excess zinc, so it must be obtained from the diet. It's needed for immune function, wound healing, blood clotting, thyroid function, and much more. It also plays a key role in maintaining vision and might have effects against viruses.

People commonly use zinc for zinc deficiency, diarrhea, and Wilson disease. Zinc is also used for acne, diabetes, anorexia, burns, and many other purposes. There is some scientific evidence to support its use for some of these conditions. But for most, there is no good scientific evidence to support its use. There is also no good evidence to support using zinc for COVID-19.


[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".