NDC 17478-717

Ketotifen Fumarate

Ketotifen Fumarate

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

Product ID17478-717_4d0739a7-7f2a-477e-a9a0-75b12c533099
NDC17478-717
Product TypeHuman Otc Drug
Proprietary NameKetotifen Fumarate
Generic NameKetotifen Fumarate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2007-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA077958
Labeler NameAkorn
Substance NameKETOTIFEN FUMARATE
Active Ingredient Strength0 mg/mL
Pharm ClassesHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 17478-717-10

1 BOTTLE, DROPPER in 1 CARTON (17478-717-10) > 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2007-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17478-717-10 [17478071710]

Ketotifen Fumarate SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA077958
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2007-10-01

NDC 17478-717-11 [17478071711]

Ketotifen Fumarate SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA077958
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-09-30

Drug Details

Active Ingredients

IngredientStrength
KETOTIFEN FUMARATE.35 mg/mL

OpenFDA Data

SPL SET ID:1376a697-bcf3-47a4-ba0d-8be7aa395c56
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311237
    • UPC Code
  • 0317478717102

    • Medicade Reported Pricing

    17478071710 KETOTIFEN FUM 0.025% EYE DROPS

    Pricing Unit: ML | Drug Type:

    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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