NDC 0065-0454

Systane

Polyethylene Glycol 400 And Propylene Glycol

Systane is a Ophthalmic Gel in the Human Otc Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Polyethylene Glycol 400; Propylene Glycol.

• Product ID: 0065-0454_09b0683d-57b7-4350-9b83-a10c3d907823
• NDC: 0065-0454
• Product Type: Human Otc Drug
• Proprietary Name: Systane
• Generic Name: Polyethylene Glycol 400 And Propylene Glycol
• Dosage Form: Gel
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2011-02-09
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part349
• Labeler Name: Alcon Laboratories, Inc.
• 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 0065-0454-07

10 mL in 1 BOTTLE, DROPPER (0065-0454-07)

• Marketing Start Date: 2011-02-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0065-0454-07 [00065045407]

Systane GEL

• Marketing Category: OTC monograph final
• Application Number: part349
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-02-11

Drug Details

Active Ingredients

Ingredient	Strength
POLYETHYLENE GLYCOL 400	4 mg/mL

OpenFDA Data

• SPL SET ID: 1d679d0f-cec2-a644-79cd-079607254bb9
• Manufacturer:
  • Alcon Laboratories, Inc.
• UNII:
  • B697894SGQ
  • 6DC9Q167V3
• RxNorm Concept Unique ID - RxCUI:
  • 895753
  • 895756

NDC Crossover Matching brand name "Systane" or generic name "Polyethylene Glycol 400 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
0065-8067	GenTeal Tears Gel Drops	polyethylene glycol 400 and propylene glycol
0065-1437	SYSTANE HYDRATION PF PRESERVATIVE FREE	Polyethylene Glycol 400 and Propylene Glycol
0065-1510	SYSTANE HYDRATION PF PRESERVATIVE FREE	Polyethylene Glycol 400 and Propylene Glycol
0065-0429	Systane Lubricant	polyethylene glycol 400 and Propylene Glycol
0065-1431	Systane Ultra	Polyethylene Glycol 400 and Propylene Glycol
0065-1507	Systane Ultra Preservative Free	Polyethylene Glycol 400 and Propylene Glycol