NDC 15821-108

FreshKote Preservative Free Lubricating Eye Drops

Povidone, Polyvinyl Alcohol

FreshKote Preservative Free Lubricating Eye Drops 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: 15821-108_67013510-fb10-4d64-8a1c-fa1abdd7402b
• NDC: 15821-108
• Product Type: Human Otc Drug
• Proprietary Name: FreshKote Preservative Free Lubricating Eye Drops
• 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 15821-108-10

1 BOTTLE, DROPPER in 1 BOX (15821-108-10) > 10 mL in 1 BOTTLE, DROPPER

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

NDC SPL Data Element Entries

NDC 15821-108-10 [15821010810]

FreshKote Preservative Free Lubricating Eye Drops SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part349
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• 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: ae2faac0-ca34-4d9b-89fd-fb889060f744
• Manufacturer:
  • FOCUS Laboratories, Inc.
• UNII:
  • 532B59J990
  • FZ989GH94E
• RxNorm Concept Unique ID - RxCUI:
  • 630977
  • 630981
• UPC Code:
  • 0315821108102

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

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