Trifluridine Solution
NDC Package 61314-044-75

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

Package Information

Trifluridine solution is a medication used to treat herpes infection of the eye. This formulation utilizes a solution delivery system. Marketed by Sandoz Inc, this product is identified by NDC 61314-044 and is authorized under FDA application ANDA074311.

Identification & Billing

NDC Package Code
61314-044-75
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 7.5 mL in 1 BOTTLE, PLASTIC
Product Code
61314-044
11-Digit Billing Format
61314004475
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Trifluridine
Non-Proprietary Name
Trifluridine
Substance Name
Trifluridine
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
TRIFLURIDINE 10 mg/mL
Pharmacologic Class
Usage Information
This medication is used to treat herpes infection of the eye. Herpes is a virus that lives in the body quietly until an outbreak is triggered. Trifluridine is not a cure for the infection, but treatment of an outbreak can speed up the healing of the sores/swelling in the eye and lower the risk of complications (e.g., vision loss).

Regulatory & Marketing

Labeler Name
Sandoz Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA074311
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-14-2001
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 61314-044-75 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 7.5 ml in 1 bottle, plastic of Trifluridine, a human prescription drug labeled by Sandoz Inc. This solution is formulated for ophthalmic use and contains trifluridine 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 Sandoz Inc on May 14, 2001. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat herpes infection of the eye. Herpes is a virus that lives in the body quietly until an outbreak is triggered. Trifluridine is not a cure for the infection, but treatment of an outbreak can speed up the healing of the sores/swelling in the eye and lower the risk of complications (e.g., vision loss).

How is this Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61314004475. 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 (5-3-2)
61314-044-75
11-Digit CMS (5-4-2)
61314-0044-75

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