NDC 58790-301

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 Advanced Vision Research (subsidiary Of Akorn, Inc.). The primary component is Ketotifen Fumarate.

Product ID58790-301_f5b013f8-7d26-4eb8-bbe8-4b5fd77c8c60
NDC58790-301
Product TypeHuman Otc Drug
Proprietary NameAllergy Eye Drops
Generic NameKetotifen Fumarate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2013-11-14
Marketing CategoryANDA / ANDA
Application NumberANDA077958
Labeler NameAdvanced Vision Research (Subsidiary of Akorn, Inc.)
Substance NameKETOTIFEN FUMARATE
Active Ingredient Strength0 mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 58790-301-02

1 BOTTLE, DROPPER in 1 CARTON (58790-301-02) > 10 mL in 1 BOTTLE, DROPPER
Marketing Start Date2013-11-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58790-301-02 [58790030102]

Allergy Eye Drops SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA077958
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-11-14
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
KETOTIFEN FUMARATE.35 mg/mL

OpenFDA Data

SPL SET ID:aa9133fd-166e-4f05-9ca8-851ece692874
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311237
    • UPC Code
  • 0050428457443

    • 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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