NDC 50804-392

Itchy Eye Drops

Ketotifen Fumarate

Itchy Eye Drops is a Ophthalmic Solution/ Drops in the Human Otc Drug category. It is labeled and distributed by Good Sense. The primary component is Ketotifen Fumarate.

Product ID50804-392_1ea5f150-3375-43ff-965e-5077f8349953
NDC50804-392
Product TypeHuman Otc Drug
Proprietary NameItchy Eye Drops
Generic NameKetotifen Fumarate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2014-06-20
Marketing CategoryANDA / ANDA
Application NumberANDA077958
Labeler NameGood Sense
Substance NameKETOTIFEN FUMARATE
Active Ingredient Strength0 mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50804-392-01

1 BOTTLE, DROPPER in 1 CARTON (50804-392-01) > 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2014-06-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50804-392-01 [50804039201]

Itchy Eye Drops SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA077958
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2014-06-20
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
KETOTIFEN FUMARATE.35 mg/mL

OpenFDA Data

SPL SET ID:61ed30dd-1878-4c8f-bef9-12ad1cc9be86
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311237
    • UPC Code
  • 0846036007336

    • NDC Crossover Matching brand name "Itchy Eye Drops" or generic name "Ketotifen Fumarate"

    NDCBrand NameGeneric Name
    46122-146Itchy Eye DropsItchy Eye Drops
    50804-392Itchy Eye DropsItchy Eye Drops
    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
    0065-4011Zaditorketotifen fumarate
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