Zinc Sulfate Injection
NDC Package 60505-6261-5

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

Package Information

Zinc Sulfate (zinc sulfate injection) injection is 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. This formulation utilizes a injection delivery system. Marketed by Apotex Corp, this product is identified by NDC 60505-6261 and is authorized under FDA application ANDA218059.

Identification & Billing

NDC Package Code
60505-6261-5
Package Description
25 VIAL in 1 CARTON / 10 mL in 1 VIAL (60505-6261-0)
Product Code
60505-6261
11-Digit Billing Format
60505626105
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zinc Sulfate
Non-Proprietary Name
Zinc Sulfate Injection
Substance Name
Zinc Sulfate, Unspecified Form
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ZINC SULFATE, UNSPECIFIED FORM 1 mg/mL
Pharmacologic Class
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
Apotex Corp
Product Type
Human Prescription Drug
FDA Application #
ANDA218059
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-15-2025
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 60505-6261-5 identifies a specific commercial package of 25 vial in 1 carton / 10 ml in 1 vial (60505-6261-0) of Zinc Sulfate, a human prescription drug labeled by Apotex Corp. This injection is formulated for intravenous use and contains zinc sulfate, unspecified form 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 Apotex Corp on January 15, 2025. The current certification is valid through December 31, 2026.

How is this Apotex Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60505626105. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (5-4-1)
60505-6261-5
11-Digit CMS (5-4-2)
60505-6261-05

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