NDC 0065-0431

Systane

Polyethylene Glycol And Propylene Glycol

Systane is a Ophthalmic Solution/ Drops in the Human Otc Drug category. It is labeled and distributed by Alcon Research Ltd. The primary component is Polyethylene Glycol 400; Propylene Glycol.

• Product ID: 0065-0431_096c8c2e-6d90-4d3c-9552-7c2ba69d2c74
• NDC: 0065-0431
• Product Type: Human Otc Drug
• Proprietary Name: Systane
• Generic Name: Polyethylene Glycol And Propylene Glycol
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2009-08-14
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part349
• Labeler Name: Alcon Research Ltd
• Substance Name: POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL
• Active Ingredient Strength: 4 mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0065-0431-33

30 VIAL in 1 CARTON (0065-0431-33) > .7 mL in 1 VIAL

• Marketing Start Date: 2015-10-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0065-0431-04 [00065043104]

Systane SOLUTION/ DROPS

• Marketing Category: OTC monograph final
• Application Number: part349
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2009-08-14
• Marketing End Date: 2017-12-31

NDC 0065-0431-32 [00065043132]

Systane SOLUTION/ DROPS

• Marketing Category: OTC monograph final
• Application Number: part349
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-10-30
• Marketing End Date: 2017-12-31

NDC 0065-0431-57 [00065043157]

Systane SOLUTION/ DROPS

• Marketing Category: OTC monograph final
• Application Number: part349
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2009-08-14
• Marketing End Date: 2011-06-30

NDC 0065-0431-33 [00065043133]

Systane SOLUTION/ DROPS

• Marketing Category: OTC monograph final
• Application Number: part349
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-10-30

Drug Details

Active Ingredients

Ingredient	Strength
POLYETHYLENE GLYCOL 400	4 mg/mL

OpenFDA Data

• SPL SET ID: 14916d2c-a63d-491e-bd91-a61f300af38a
• Manufacturer:
  • Alcon Research Ltd
• UNII:
  • B697894SGQ
  • 6DC9Q167V3
• RxNorm Concept Unique ID - RxCUI:
  • 477589
  • 707566

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

NDC	Brand Name	Generic Name
0065-0431	Systane	polyethylene glycol and propylene glycol
0065-0454	Systane	polyethylene glycol 400 and propylene glycol
0065-0474	Systane	hypromellose
0065-1432	Systane	polyethylene glycol 400 and propylene glycol
70000-0088	Dry eye relief	polyethylene glycol and propylene glycol
65923-843	Systane Ultra Single Vials	Polyethylene Glycol and Propylene Glycol