NDC 58790-008

Ketotifen Fumarate

Ketotifen Fumarate

Ketotifen Fumarate is a Ophthalmic Solution 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 ID58790-008_1690a8bc-16a9-49d3-a554-ce976662e36e
NDC58790-008
Product TypeHuman Otc Drug
Proprietary NameKetotifen Fumarate
Generic NameKetotifen Fumarate
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date2012-03-15
Marketing CategoryANDA / ANDA
Application NumberANDA077958
Labeler NameAdvanced Vision Research (Subsidiary of Akorn, Inc.)
Substance NameKETOTIFEN FUMARATE
Active Ingredient Strength0 mg/mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 58790-008-10

1 BOTTLE, DROPPER in 1 CARTON (58790-008-10) > 10 mL in 1 BOTTLE, DROPPER
Marketing Start Date2012-03-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58790-008-10 [58790000810]

Ketotifen Fumarate SOLUTION
Marketing CategoryANDA
Application NumberANDA077958
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-10-08
Inactivation Date2020-01-31

NDC 58790-008-05 [58790000805]

Ketotifen Fumarate SOLUTION
Marketing CategoryANDA
Application NumberANDA077958
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-03-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
KETOTIFEN FUMARATE.35 mg/mL

OpenFDA Data

SPL SET ID:39856d6d-31ed-4184-9831-b40efdf4dcf4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311237
    • UPC Code
  • 0358790008059
  • 0358790008103

    • 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.