NDC 0065-1431

Systane Ultra

Polyethylene Glycol 400 And Propylene Glycol

Systane Ultra is a Ophthalmic Solution/ Drops 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 ID0065-1431_22a90eb2-bae4-4c23-a66b-814ae1196dc8
NDC0065-1431
Product TypeHuman Otc Drug
Proprietary NameSystane Ultra
Generic NamePolyethylene Glycol 400 And Propylene Glycol
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2014-10-01
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 0065-1431-01

1 BOTTLE, DROPPER in 1 CARTON (0065-1431-01) > 1.5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2014-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0065-1431-01 [00065143101]

Systane Ultra SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-10-01

NDC 0065-1431-88 [00065143188]

Systane Ultra SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-03-01
Marketing End Date2017-09-11

NDC 0065-1431-21 [00065143121]

Systane Ultra SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-10-01

NDC 0065-1431-05 [00065143105]

Systane Ultra SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2009-11-30

NDC 0065-1431-80 [00065143180]

Systane Ultra SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-10-01

NDC 0065-1431-41 [00065143141]

Systane Ultra SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2014-10-01

NDC 0065-1431-18 [00065143118]

Systane Ultra SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2014-10-01

NDC 0065-1431-31 [00065143131]

Systane Ultra SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-10-01

NDC 0065-1431-28 [00065143128]

Systane Ultra SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2014-10-01

Drug Details

Active Ingredients

IngredientStrength
POLYETHYLENE GLYCOL 4004 mg/mL

OpenFDA Data

SPL SET ID:1f3a65f4-1a76-5a1d-5169-1029ad00df1f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 477589
  • 707566
  • NDC Crossover Matching brand name "Systane Ultra" or generic name "Polyethylene Glycol 400 And Propylene Glycol"

    NDCBrand NameGeneric Name
    0065-1431Systane UltraPolyethylene Glycol 400 and Propylene Glycol
    0065-8067GenTeal Tears Gel Dropspolyethylene glycol 400 and propylene glycol
    11673-522Lubricant dropsPolyethylene Glycol 400 and Propylene Glycol
    0363-0307Lubricant EyePolyethylene Glycol 400 and Propylene Glycol
    0363-6451Lubricant EyePolyethylene Glycol 400 and Propylene Glycol
    11822-2701lubricant eyePolyethylene Glycol 400 and Propylene Glycol
    30142-327lubricating reliefPolyethylene Glycol 400 and Propylene Glycol
    46122-199PEG-Phen Lubricant Eye DropsPolyethylene Glycol 400 and Propylene Glycol
    46122-201PEG-Phen Ultra Lubricant Eye DropsPolyethylene Glycol 400 and Propylene Glycol
    11822-4540RITE AID lubricant dropspolyethylene glycol 400 and propylene glycol
    0065-0454Systanepolyethylene glycol 400 and propylene glycol
    0065-1432Systanepolyethylene 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
    0065-1507Systane Ultra Preservative FreePolyethylene Glycol 400 and Propylene Glycol
    0363-7267Walgreens Lubricant EyePolyethylene Glycol 400 and Propylene Glycol

    Trademark Results [Systane Ultra]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SYSTANE ULTRA
    SYSTANE ULTRA
    77319393 3457632 Live/Registered
    NOVARTIS AG
    2007-11-01

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