Floril Tears
NDC Package 16995-002-04

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Floril Tears is put 1 to 2 drops in the affected eyes up to times daily. Marketed by Vitaline S.a.c., this product is identified by NDC 16995-002 and is authorized under FDA application part349.

Identification & Billing

NDC Package Code
16995-002-04
Package Description
30 mL in 1 BOTTLE, DROPPER
Product Code
16995-002
11-Digit Billing Format
16995000204
RxNorm Crosswalk
  • RxCUI: 1039905 - polyethylene glycol 400 0.2 % / polyvinyl alcohol 1.4 % Ophthalmic Solution
  • RxCUI: 1039905 - polyethylene glycol 400 2 MG/ML / polyvinyl alcohol 0.014 ML/ML Ophthalmic Solution
  • RxCUI: 1039907 - Floril TEARS 0.2 % / 1.4 % Ophthalmic Solution
  • RxCUI: 1039907 - polyethylene glycol 400 2 MG/ML / polyvinyl alcohol 0.014 ML/ML Ophthalmic Solution [Floril Tears]
  • RxCUI: 1039907 - Floril Tears (polyethylene glycol 400 0.2 % / polyvinyl alcohol 1.4 % ) Ophthalmic Solution

Clinical Specifications

Proprietary Name
Floril Tears
Dosage Form
-
Usage Information
Put 1 to 2 drops in the affected eyes up to times daily.

Regulatory & Marketing

Labeler Name
Vitaline S.a.c.
FDA Application #
part349
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
11-10-2005
Listing Expiration
12-31-2017
Exclude Flag
I
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 (16995-002). Click a package code to view its specific billing and regulatory data.

16995-002-01
3 mL in 1 BOTTLE, DROPPER
16995-002-02
10 mL in 1 BOTTLE, DROPPER
16995-002-03
15 mL in 1 BOTTLE, DROPPER

* 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 16995-002-04 identifies a specific commercial package of 30 ml in 1 bottle, dropper of Floril Tears, labeled by Vitaline S.a.c.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Vitaline S.a.c. on November 10, 2005. The current certification is valid through December 31, 2017.

How is this Vitaline S.a.c. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16995000204. 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)
16995-002-04
11-Digit CMS (5-4-2)
16995-0002-04

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