NDC 15821-105

FreshKote Preservative Free Lubricating Eye Drops Single Use

Povidone, Polyvinyl Alcohol

FreshKote Preservative Free Lubricating Eye Drops Single Use is a Ophthalmic Solution in the Human Otc Drug category. It is labeled and distributed by Focus Laboratories, Inc.. The primary component is Povidone; Polyvinyl Alcohol, Unspecified.

• Product ID: 15821-105_95b926fe-97b4-4c12-814e-6a76c6ca8c23
• NDC: 15821-105
• Product Type: Human Otc Drug
• Proprietary Name: FreshKote Preservative Free Lubricating Eye Drops Single Use
• Generic Name: Povidone, Polyvinyl Alcohol
• Dosage Form: Solution
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2018-06-29
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part349
• Labeler Name: FOCUS Laboratories, Inc.
• Substance Name: POVIDONE; POLYVINYL ALCOHOL, UNSPECIFIED
• Active Ingredient Strength: 20 g/1000mL; g/1000mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 15821-105-03

6 POUCH in 1 BOX (15821-105-03) > 5 BOTTLE, UNIT-DOSE in 1 POUCH > .3 mL in 1 BOTTLE, UNIT-DOSE

• Marketing Start Date: 2018-06-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 15821-105-03 [15821010503]

FreshKote Preservative Free Lubricating Eye Drops Single Use SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part349
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-06-29
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
POVIDONE	20 g/1000mL

OpenFDA Data

• SPL SET ID: be2f3b44-f371-4504-86d3-292cc8dfa062
• Manufacturer:
  • FOCUS Laboratories, Inc.
• UNII:
  • 532B59J990
  • FZ989GH94E
• RxNorm Concept Unique ID - RxCUI:
  • 630977
  • 630981
• UPC Code:
  • 0315821105033

NDC Crossover Matching brand name "FreshKote Preservative Free Lubricating Eye Drops Single Use" or generic name "Povidone, Polyvinyl Alcohol"

NDC	Brand Name	Generic Name
15821-105	FreshKote Preservative Free Lubricating Eye Drops Single Use	Povidone, Polyvinyl Alcohol
71776-001	FreshKote Preservative Free Lubricant Eye Drops	Povidone, Polyvinyl Alcohol
15821-108	FreshKote Preservative Free Lubricating Eye Drops	Povidone, Polyvinyl Alcohol