NDC 0065-4011

Zaditor

Ketotifen Fumarate

Zaditor is a Ophthalmic Solution in the Human Otc Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Ketotifen Fumarate.

Product ID0065-4011_0797cdc3-0dbe-4034-b406-35267047c03a
NDC0065-4011
Product TypeHuman Otc Drug
Proprietary NameZaditor
Generic NameKetotifen Fumarate
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date2012-12-21
Marketing CategoryANDA / ANDA
Application NumberANDA077200
Labeler NameAlcon Laboratories, Inc.
Substance NameKETOTIFEN FUMARATE
Active Ingredient Strength0 mg/mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0065-4011-05

1 BOTTLE, DROPPER in 1 CARTON (0065-4011-05) > 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2012-12-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0065-4011-05 [00065401105]

Zaditor SOLUTION
Marketing CategoryANDA
Application NumberANDA077200
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2012-12-21

NDC 0065-4011-11 [00065401111]

Zaditor SOLUTION
Marketing CategoryANDA
Application NumberANDA077200
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-12-21

NDC 0065-4011-06 [00065401106]

Zaditor SOLUTION
Marketing CategoryANDA
Application NumberANDA077200
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2012-12-21

Drug Details

Active Ingredients

IngredientStrength
KETOTIFEN FUMARATE.25 mg/mL

OpenFDA Data

SPL SET ID:ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311237
  • 284380

    • NDC Crossover Matching brand name "Zaditor" or generic name "Ketotifen Fumarate"

    NDCBrand NameGeneric Name
    0065-4011Zaditorketotifen fumarate
    50090-1037ZaditorZaditor
    24208-601AlawayKetotifen Fumarate
    24208-600Alaway Preservative Freeketotifen fumarate
    11822-5533Eye Itch ReleifKetotifen Fumarate
    0363-0038Eye Itch Reliefketotifen fumarate
    0363-0610EYE ITCH RELIEFKetotifen Fumarate
    0536-1096Eye Itch ReliefKetotifen Fumarate
    11673-064Eye Itch Reliefketotifen fumarate
    11822-4201eye itch reliefketotifen fumarate
    11822-4202eye itch reliefketotifen fumarate
    21130-601Eye Itch ReliefKetotifen Fumarate
    0179-8601Ketotifen FumarateKetotifen Fumarate
    0363-9060Ketotifen FumarateKetotifen Fumarate
    0536-1222Ketotifen FumarateKetotifen Fumarate
    0536-1252Ketotifen FumarateKetotifen Fumarate
    17478-717Ketotifen FumarateKetotifen Fumarate
    11716-1163LEADER EYE ITCH RELIEF DROPSKETOTIFEN FUMARATE

    Trademark Results [Zaditor]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZADITOR
    ZADITOR
    75680062 2767030 Live/Registered
    Novartis AG
    1999-04-30
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.