NDC 65923-843

Systane Ultra Single Vials

Polyethylene Glycol And Propylene Glycol

Systane Ultra Single Vials is a Ophthalmic Solution/ Drops in the Human Otc Drug category. It is labeled and distributed by United Exchange Corp.. The primary component is Propylene Glycol; Polyethylene Glycol 400.

• Product ID: 65923-843_638a4320-9c1b-4122-e053-2991aa0af758
• NDC: 65923-843
• Product Type: Human Otc Drug
• Proprietary Name: Systane Ultra Single Vials
• Generic Name: Polyethylene Glycol And Propylene Glycol
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2017-01-02
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part349
• Labeler Name: United Exchange Corp.
• Substance Name: PROPYLENE GLYCOL; POLYETHYLENE GLYCOL 400
• Active Ingredient Strength: 3 mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 65923-843-04

.4 mL in 1 VIAL (65923-843-04)

• Marketing Start Date: 2017-01-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65923-843-04 [65923084304]

Systane Ultra Single Vials SOLUTION/ DROPS

• Marketing Category: OTC monograph final
• Application Number: part349
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-01-02
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
PROPYLENE GLYCOL	3 mg/mL

OpenFDA Data

• SPL SET ID: 638a4320-9c1a-4122-e053-2991aa0af758
• Manufacturer:
  • United Exchange Corp.
• UNII:
  • B697894SGQ
  • 6DC9Q167V3
• RxNorm Concept Unique ID - RxCUI:
  • 477589
  • 707566

NDC Crossover Matching brand name "Systane Ultra Single Vials" or generic name "Polyethylene Glycol And Propylene Glycol"

NDC	Brand Name	Generic Name
65923-843	Systane Ultra Single Vials	Polyethylene Glycol and Propylene Glycol
70000-0088	Dry eye relief	polyethylene glycol and propylene glycol
0065-0431	Systane	polyethylene glycol and propylene glycol