NDC 49781-078

Allergy Eye Drops

Ketotifen Fumarate

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

Product ID49781-078_c340fbc9-bf97-462b-a777-b10cbbbbeab4
NDC49781-078
Product TypeHuman Otc Drug
Proprietary NameAllergy Eye Drops
Generic NameKetotifen Fumarate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2014-01-13
Marketing CategoryANDA / ANDA
Application NumberANDA077958
Labeler NameCardinal Health
Substance NameKETOTIFEN FUMARATE
Active Ingredient Strength0 mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 49781-078-71

1 BOTTLE, DROPPER in 1 CARTON (49781-078-71) > 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2014-01-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49781-078-71 [49781007871]

Allergy Eye Drops SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA077958
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2014-01-13
Marketing End Date2016-07-01

Drug Details

Active Ingredients

IngredientStrength
KETOTIFEN FUMARATE.35 mg/mL

OpenFDA Data

SPL SET ID:d0a8f488-5193-4aa9-bd77-711fc002b244
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311237
  • UPC Code
  • 0096295125269
  • NDC Crossover Matching brand name "Allergy Eye Drops" or generic name "Ketotifen Fumarate"

    NDCBrand NameGeneric Name
    68016-450Allergy Eye DropsAllergy Eye Drops
    37808-870Allergy Eye DropsAllergy Eye Drops
    49781-078Allergy Eye DropsAllergy Eye Drops
    58790-301Allergy Eye DropsAllergy Eye Drops
    59779-366ALLERGY EYE DROPSALLERGY 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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