Systane Solution/ Drops
NDC Package 0065-1432-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Systane (polyethylene glycol 400 and propylene glycol) solution/ dropses is instill 1 or 2 drops in the affected eye(s) as needed. This formulation utilizes a solution/ drops delivery system. Marketed by Alcon Laboratories, Inc., this product is identified by NDC 0065-1432 and is authorized under FDA application M018.

Identification & Billing

NDC Package Code
0065-1432-01
Package Description
24 VIAL in 1 CARTON / .4 mL in 1 VIAL
Product Code
11-Digit Billing Format
00065143201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 477589 - polyethylene glycol 400, 0.4 % / propylene glycol 0.3 % Ophthalmic Solution
  • RxCUI: 477589 - polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic Solution
  • RxCUI: 477589 - PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic Solution

Clinical Specifications

Proprietary Name
Systane Ultra
Non-Proprietary Name
Polyethylene Glycol 400 And Propylene Glycol
Substance Name
Polyethylene Glycol 400; Propylene Glycol
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Ophthalmic - Administration to the external eye.
Usage Information
Instill 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
07-27-2009
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0065-1432). Click a package code to view its specific billing and regulatory data.

4 VIAL in 1 CARTON / .4 mL in 1 VIAL
72 VIAL in 1 CARTON / .4 mL in 1 VIAL
5 VIAL in 1 CARTON / .7 mL in 1 VIAL
60 VIAL in 1 CARTON / .7 mL in 1 VIAL
25 VIAL in 1 CARTON / .7 mL in 1 VIAL

* 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 0065-1432-01 identifies a specific commercial package of 24 vial in 1 carton / .4 ml in 1 vial of Systane Ultra, a human over the counter drug labeled by Alcon Laboratories, Inc.. This solution/ drops is formulated for ophthalmic use and contains polyethylene glycol 400; 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 July 27, 2009. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00065143201. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
0065-1432-01
11-Digit CMS (5-4-2)
00065-1432-01

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