NDC 70518-1142

Ketotifen Fumarate

Ketotifen Fumarate

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

Product ID70518-1142_6c482648-c74d-b7dc-e053-2991aa0a3d52
NDC70518-1142
Product TypeHuman Otc Drug
Proprietary NameKetotifen Fumarate
Generic NameKetotifen Fumarate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2018-04-27
Marketing CategoryANDA / ANDA
Application NumberANDA077958
Labeler NameREMEDYREPACK INC.
Substance NameKETOTIFEN FUMARATE
Active Ingredient Strength0 mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-1142-0

1 BOTTLE, DROPPER in 1 CARTON (70518-1142-0) > 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2018-04-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1142-0 [70518114200]

Ketotifen Fumarate SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA077958
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-04-27

Drug Details

Active Ingredients

IngredientStrength
KETOTIFEN FUMARATE.35 mg/mL

OpenFDA Data

SPL SET ID:0c15b414-85af-4df5-8167-3ee4224de4a8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311237
  • NDC Crossover Matching brand name "Ketotifen Fumarate" or generic name "Ketotifen Fumarate"

    NDCBrand NameGeneric Name
    0179-8601Ketotifen FumarateKetotifen Fumarate
    0363-9060Ketotifen FumarateKetotifen Fumarate
    0536-1222Ketotifen FumarateKetotifen Fumarate
    0536-1252Ketotifen FumarateKetotifen Fumarate
    17478-717Ketotifen FumarateKetotifen Fumarate
    69842-600Ketotifen FumarateKetotifen Fumarate
    69842-601Ketotifen FumarateKetotifen Fumarate
    70518-1142Ketotifen FumarateKetotifen Fumarate
    71205-115Ketotifen FumarateKetotifen Fumarate
    58790-008Ketotifen FumarateKetotifen Fumarate
    59779-627Ketotifen FumarateKetotifen Fumarate
    59779-330Ketotifen FumarateKetotifen Fumarate
    70677-0052Ketotifen FumarateKetotifen Fumarate
    62011-0379Ketotifen FumarateKetotifen Fumarate
    60505-6215Ketotifen FumarateKetotifen Fumarate
    46122-304Ketotifen FumarateKetotifen Fumarate
    46122-634Ketotifen FumarateKetotifen Fumarate
    72189-114KETOTIFEN FUMARATEKETOTIFEN FUMARATE
    70518-2867Ketotifen FumarateKetotifen Fumarate
    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
    11716-1163LEADER EYE ITCH RELIEF DROPSKETOTIFEN FUMARATE
    0065-4011Zaditorketotifen fumarate

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