Arsenic Trioxide Injection
NDC Package 68083-535-10

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

Package Information

Arsenic Trioxide injection is arsenic trioxide is used to treat a type of leukemia (acute promyelocytic leukemia-APL). This formulation utilizes a injection delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-535 and is authorized under FDA application ANDA215059.

Identification & Billing

NDC Package Code
68083-535-10
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE
Product Code
68083-535
11-Digit Billing Format
68083053510
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Arsenic Trioxide
Non-Proprietary Name
Arsenic Trioxide
Substance Name
Arsenic Trioxide
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)
ARSENIC TRIOXIDE 1 mg/mL
Usage Information
Arsenic trioxide is used to treat a type of leukemia (acute promyelocytic leukemia-APL).

Regulatory & Marketing

Labeler Name
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA215059
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-22-2022
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 68083-535-10 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose of Arsenic Trioxide, a human prescription drug labeled by Gland Pharma Limited. This injection is formulated for intravenous use and contains arsenic trioxide 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 Gland Pharma Limited on April 22, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Arsenic trioxide is used to treat a type of leukemia (acute promyelocytic leukemia-APL).

How is this Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083053510. 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)
68083-535-10
11-Digit CMS (5-4-2)
68083-0535-10

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