NDC 41250-303

Itchy Eye

Ketotifen Fumarate

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

Product ID41250-303_095bec2c-97d8-45a3-be5f-e3601c017a6f
NDC41250-303
Product TypeHuman Otc Drug
Proprietary NameItchy Eye
Generic NameKetotifen Fumarate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2016-01-26
Marketing CategoryANDA / ANDA
Application NumberANDA077958
Labeler NameMeijer Distribution Inc
Substance NameKETOTIFEN FUMARATE
Active Ingredient Strength0 mg/mL
Pharm ClassesHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 41250-303-01

1 BOTTLE, DROPPER in 1 CARTON (41250-303-01) > 10 mL in 1 BOTTLE, DROPPER
Marketing Start Date2016-01-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 41250-303-01 [41250030301]

Itchy Eye SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA077958
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-01-26

Drug Details

Active Ingredients

IngredientStrength
KETOTIFEN FUMARATE.35 mg/mL

OpenFDA Data

SPL SET ID:11c16152-6feb-45c9-99e3-af514caa2681
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311237

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

    NDCBrand NameGeneric Name
    30142-770Itchy EyeItchy Eye
    41250-303Itchy EyeItchy Eye
    41250-870Itchy EyeItchy Eye
    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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