71776-001 NDC - FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS ()

Drug Information

  • Product NDC: 71776-001
  • Proprietary Name: FreshKote Preservative Free Lubricant Eye Drops
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Eyevance Pharmaceuticals
Product Type:
FDA Application Number: M018
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:3/13/2019

Package Information

No. Package Code Package Description Billing Unit
171776-001-0330 VIAL, SINGLE-USE in 1 BOX (71776-001-03) / .3 mL in 1 VIAL, SINGLE-USE
271776-001-101 BOTTLE, DROPPER in 1 BOX (71776-001-10) / 10 mL in 1 BOTTLE, DROPPERML

NDC Record

Field Name Field Value Definition
PRODUCT NDC71776-001The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEFreshKote Preservative Free Lubricant Eye DropsThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE3/13/2019This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH DRUGProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERM018This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEEyevance PharmaceuticalsName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 12/19/2025

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