NDC 71776-001

FreshKote Preservative Free Lubricant Eye Drops

Povidone, Polyvinyl Alcohol

FreshKote Preservative Free Lubricant Eye Drops is a Ophthalmic Solution in the Human Otc Drug category. It is labeled and distributed by Eyevance Pharmaceuticals. The primary component is Povidone; Polyvinyl Alcohol, Unspecified.

Product ID71776-001_841055b1-2395-1c37-e053-2991aa0a9ceb
NDC71776-001
Product TypeHuman Otc Drug
Proprietary NameFreshKote Preservative Free Lubricant Eye Drops
Generic NamePovidone, Polyvinyl Alcohol
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date2019-03-13
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart349
Labeler NameEyevance Pharmaceuticals
Substance NamePOVIDONE; POLYVINYL ALCOHOL, UNSPECIFIED
Active Ingredient Strength20 g/1000mL; g/1000mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71776-001-03

30 VIAL, SINGLE-USE in 1 BOX (71776-001-03) > .3 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2020-12-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71776-001-10 [71776000110]

FreshKote Preservative Free Lubricant Eye Drops SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2019-03-13

Drug Details

Active Ingredients

IngredientStrength
POVIDONE20 g/1000mL

OpenFDA Data

SPL SET ID:f51c50c3-43ae-4169-9d2b-22b239461dd1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 630977
  • 630981
  • UPC Code
  • 0371776001103
  • NDC Crossover Matching brand name "FreshKote Preservative Free Lubricant Eye Drops" or generic name "Povidone, Polyvinyl Alcohol"

    NDCBrand NameGeneric Name
    71776-001FreshKote Preservative Free Lubricant Eye DropsPovidone, Polyvinyl Alcohol
    81372-002Freshkote Preservative Free Lubricant Eye DropsPOLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE
    15821-108FreshKote Preservative Free Lubricating Eye DropsPovidone, Polyvinyl Alcohol
    15821-105FreshKote Preservative Free Lubricating Eye Drops Single UsePovidone, Polyvinyl Alcohol

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