NDC 11716-1163

LEADER EYE ITCH RELIEF DROPS

Ketotifen Fumarate

LEADER EYE ITCH RELIEF DROPS is a Ophthalmic Solution/ Drops in the Human Otc Drug category. It is labeled and distributed by Hanlim Pharm. Co., Ltd.. The primary component is Ketotifen Fumarate.

Product ID11716-1163_2fd8e64f-8fa0-43d6-b48d-a1246b7e557a
NDC11716-1163
Product TypeHuman Otc Drug
Proprietary NameLEADER EYE ITCH RELIEF DROPS
Generic NameKetotifen Fumarate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2010-04-21
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart349
Labeler NameHANLIM PHARM. CO., LTD.
Substance NameKETOTIFEN FUMARATE
Active Ingredient Strength0 mg/mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 11716-1163-7

1 BOTTLE in 1 CARTON (11716-1163-7) > 5 mL in 1 BOTTLE
Marketing Start Date2010-04-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11716-1163-7 [11716116307]

LEADER EYE ITCH RELIEF DROPS SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-04-21
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
KETOTIFEN FUMARATE.345 mg/mL

OpenFDA Data

SPL SET ID:7e6c8a0c-31ea-429b-890b-544142805790
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311237
    • UPC Code
  • 0096295116373

    • NDC Crossover Matching brand name "LEADER EYE ITCH RELIEF DROPS" or generic name "Ketotifen Fumarate"

    NDCBrand NameGeneric Name
    11716-1163LEADER EYE ITCH RELIEF DROPSKETOTIFEN 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
    0179-8601Ketotifen FumarateKetotifen Fumarate
    0363-9060Ketotifen FumarateKetotifen Fumarate
    0536-1222Ketotifen FumarateKetotifen Fumarate
    0536-1252Ketotifen FumarateKetotifen Fumarate
    17478-717Ketotifen FumarateKetotifen Fumarate
    0065-4011Zaditorketotifen fumarate
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