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 ID0065-0454_09b0683d-57b7-4350-9b83-a10c3d907823
NDC0065-0454
Product TypeHuman Otc Drug
Proprietary NameSystane
Generic NamePolyethylene Glycol 400 And Propylene Glycol
Dosage FormGel
Route of AdministrationOPHTHALMIC
Marketing Start Date2011-02-09
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart349
Labeler NameAlcon Laboratories, Inc.
Substance NamePOLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL
Active Ingredient Strength4 mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0065-0454-07

10 mL in 1 BOTTLE, DROPPER (0065-0454-07)
Marketing Start Date2011-02-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0065-0454-07 [00065045407]

Systane GEL
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2011-02-11

Drug Details

Active Ingredients

IngredientStrength
POLYETHYLENE GLYCOL 4004 mg/mL

OpenFDA Data

SPL SET ID:1d679d0f-cec2-a644-79cd-079607254bb9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 895753
  • 895756
  • NDC Crossover Matching brand name "Systane" or generic name "Polyethylene Glycol 400 And Propylene Glycol"

    NDCBrand NameGeneric Name
    0065-0431Systanepolyethylene glycol and propylene glycol
    0065-0454Systanepolyethylene glycol 400 and propylene glycol
    0065-0474Systanehypromellose
    0065-1432Systanepolyethylene glycol 400 and propylene glycol
    0065-8067GenTeal Tears Gel Dropspolyethylene glycol 400 and propylene glycol
    0065-1437SYSTANE HYDRATION PF PRESERVATIVE FREEPolyethylene Glycol 400 and Propylene Glycol
    0065-1510SYSTANE HYDRATION PF PRESERVATIVE FREEPolyethylene Glycol 400 and Propylene Glycol
    0065-0429Systane Lubricantpolyethylene glycol 400 and Propylene Glycol
    0065-1431Systane UltraPolyethylene Glycol 400 and Propylene Glycol
    0065-1507Systane Ultra Preservative FreePolyethylene Glycol 400 and Propylene Glycol

    Trademark Results [Systane]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SYSTANE
    SYSTANE
    98186374 not registered Live/Pending
    Alcon Inc.
    2023-09-19
    SYSTANE
    SYSTANE
    90138725 not registered Live/Pending
    Alcon Inc.
    2020-08-26
    SYSTANE
    SYSTANE
    85909669 4432556 Live/Registered
    Alcon Inc.
    2013-04-19
    SYSTANE
    SYSTANE
    85314277 4365194 Live/Registered
    ALCON INC.
    2011-05-06
    SYSTANE
    SYSTANE
    78144304 2799326 Live/Registered
    NOVARTIS AG
    2002-07-16

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