Systane Pro Pf Emulsion
NDC Package 0065-9308-06

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

Package Information

Systane Pro Pf (propylene glycol) emulsions is shake well before usingput 1 or 2 drops in the affected eye(s) as needed. This formulation utilizes a emulsion delivery system. Marketed by Alcon Laboratories, Inc., this product is identified by NDC 0065-9308 and is authorized under FDA application M018.

Identification & Billing

NDC Package Code
0065-9308-06
Package Description
32 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE
Product Code
0065-9308
11-Digit Billing Format
00065930806
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Systane Pro Pf
Non-Proprietary Name
Propylene Glycol
Substance Name
Propylene Glycol
Dosage Form
Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
PROPYLENE GLYCOL 6 mg/mL
Usage Information
Shake well before usingput 1 or 2 drops in the affected eye(s) as needed

Regulatory & Marketing

Labeler Name
Alcon Laboratories, Inc.
Product Type
Human Otc Drug
FDA Application #
M018
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-14-2025
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0065-9308). Click a package code to view its specific billing and regulatory data.

0065-9308-05
5 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE

* 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 0065-9308-06 identifies a specific commercial package of 32 vial, single-dose in 1 carton / .5 ml in 1 vial, single-dose of Systane Pro Pf, a human over the counter drug labeled by Alcon Laboratories, Inc.. This emulsion is formulated for ophthalmic use and contains propylene glycol 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 Alcon Laboratories, Inc. on March 14, 2025. The current certification is valid through December 31, 2027.

How is this Alcon Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00065930806. 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 (4-4-2)
0065-9308-06
11-Digit CMS (5-4-2)
00065-9308-06

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