NDC 0179-8601

Ketotifen Fumarate

Ketotifen Fumarate

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

Product ID0179-8601_6b1d3946-be1f-4104-9965-f6bb58695082
NDC0179-8601
Product TypeHuman Otc Drug
Proprietary NameKetotifen Fumarate
Generic NameKetotifen Fumarate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2011-11-08
Marketing CategoryANDA / ANDA
Application NumberANDA077958
Labeler NameKAISER FOUNDATION HOSPITALS
Substance NameKETOTIFEN FUMARATE
Active Ingredient Strength0 mg/mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0179-8601-05

1 BOTTLE, DROPPER in 1 CARTON (0179-8601-05) > 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2011-11-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0179-8601-05 [00179860105]

Ketotifen Fumarate SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA077958
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2011-11-08
Marketing End Date2020-11-01

Drug Details

Active Ingredients

IngredientStrength
KETOTIFEN FUMARATE.35 mg/mL

OpenFDA Data

SPL SET ID:14a5dbbb-71ed-4c14-818f-accc2efe0020
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311237
  • UPC Code
  • 0301798601050
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.