NDC 16995-004 Floril Tears

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
16995-004
Proprietary Name:
Floril Tears
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Labeler Code:
16995
Start Marketing Date: [9]
11-10-2005
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
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Product Details

What is NDC 16995-004?

The NDC code 16995-004 is assigned by the FDA to the product Floril Tears which is product labeled by Vitaline S.a.c.. The product's dosage form is . The product is distributed in 4 packages with assigned NDC codes 16995-004-01 3 ml in 1 bottle, dropper , 16995-004-02 10 ml in 1 bottle, dropper , 16995-004-03 15 ml in 1 bottle, dropper , 16995-004-04 30 ml in 1 bottle, dropper . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Floril Tears?

Put 1 to 2 drops in the affected eyes up to times daily.

Which are Floril Tears UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Floril Tears Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Floril Tears?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".