Foscarnet Sodium Injection, Solution
NDC Package 68083-389-01

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

Package Information

Foscarnet Sodium injection is cMV RetinitisFoscarnet sodium Injection is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). This formulation utilizes a injection, solution delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-389 and is authorized under FDA application ANDA213001.

Identification & Billing

NDC Package Code
68083-389-01
Package Description
1 BAG in 1 CARTON / 250 mL in 1 BAG
Product Code
68083-389
11-Digit Billing Format
68083038901
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Foscarnet Sodium
Non-Proprietary Name
Foscarnet Sodium
Substance Name
Foscarnet Sodium
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
FOSCARNET SODIUM 24 mg/mL
Pharmacologic Class
Usage Information
CMV RetinitisFoscarnet sodium Injection is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Combination therapy with foscarnet sodium Injection and ganciclovir is indicated for patients who have relapsed after monotherapy with either drug. SAFETY AND EFFICACY OF FOSCARNET SODIUM INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (e.g., PNEUMONITIS, GASTROENTERITIS); CONGENITAL OR NEONATAL CMV DISEASE; OR NONIMMUNOCOMPROMISED INDIVIDUALS.Mucocutaneous Acyclovir Resistant HSV InfectionsFoscarnet sodium Injection is indicated for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients. SAFETY AND EFFICACY OF FOSCARNET SODIUM INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER HSV INFECTIONS (e.g., RETINITIS, ENCEPHALITIS); CONGENITAL OR NEONATAL HSV DISEASE; OR HSV IN NONIMMUNOCOMPROMISED INDIVIDUALS.

Regulatory & Marketing

Labeler Name
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA213001
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-21-2021
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 68083-389-01 identifies a specific commercial package of 1 bag in 1 carton / 250 ml in 1 bag of Foscarnet Sodium, a human prescription drug labeled by Gland Pharma Limited. This injection, solution is formulated for intravenous use and contains foscarnet sodium 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 21, 2021. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083038901. 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)
68083-389-01
11-Digit CMS (5-4-2)
68083-0389-01

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