Zinc Sulfate
NDC Package 75834-271-25

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Zinc Sulfate is injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Marketed by Nivagen Pharmaceuticals, Inc., this product is identified by NDC 75834-271 and is authorized under FDA application ANDA214597.

Identification & Billing

NDC Package Code
75834-271-25
Package Description
25 VIAL in 1 TRAY / 10 mL in 1 VIAL (75834-271-01)
Product Code
75834-271
11-Digit Billing Format
75834027125
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zinc Sulfate
Dosage Form
-
Usage Information
Zinc Sulfate Injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.

Regulatory & Marketing

Labeler Name
Nivagen Pharmaceuticals, Inc.
FDA Application #
ANDA214597
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-30-2024
Listing Expiration
12-31-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 75834-271-25 identifies a specific commercial package of 25 vial in 1 tray / 10 ml in 1 vial (75834-271-01) of Zinc Sulfate, labeled by Nivagen Pharmaceuticals, Inc.. 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 Nivagen Pharmaceuticals, Inc. on July 30, 2024. The current certification is valid through December 31, 2025.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75834027125. 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)
75834-271-25
11-Digit CMS (5-4-2)
75834-0271-25

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