NDC 49348-107

eye itch relief

Ketotifen Fumarate

eye itch relief is a Ophthalmic Solution/ Drops in the Human Otc Drug category. It is labeled and distributed by Strategic Sourcing Services Llc. The primary component is Ketotifen Fumarate.

Product ID49348-107_24adab31-1a43-43bc-ae11-4c00bc122c31
NDC49348-107
Product TypeHuman Otc Drug
Proprietary Nameeye itch relief
Generic NameKetotifen Fumarate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2014-02-07
Marketing CategoryANDA / ANDA
Application NumberANDA077958
Labeler NameSTRATEGIC SOURCING SERVICES LLC
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 49348-107-17

1 BOTTLE, DROPPER in 1 CARTON (49348-107-17) > 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2014-02-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49348-107-17 [49348010717]

eye itch relief SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA077958
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2014-02-07

Drug Details

Active Ingredients

IngredientStrength
KETOTIFEN FUMARATE.35 mg/mL

OpenFDA Data

SPL SET ID:1ff86d21-cf4b-4a53-9d73-be331160c37a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311237
  • UPC Code
  • 0010939684448
  • Medicade Reported Pricing

    49348010717 SM EYE ITCH RELIEF 0.025% DROP

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "eye itch relief" or generic name "Ketotifen Fumarate"

    NDCBrand NameGeneric Name
    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
    68016-403Eye Itch ReliefEye Itch Relief
    70000-0124Eye Itch ReliefEye Itch Relief
    37808-802Eye Itch ReliefEye Itch Relief
    46122-163Eye Itch ReliefEye Itch Relief
    49781-075Eye Itch ReliefEye Itch Relief
    49348-107eye itch reliefeye itch relief
    50804-302Eye Itch ReliefEye Itch Relief
    59779-705Eye Itch ReliefEye Itch Relief
    59779-920Eye Itch ReliefEye Itch Relief
    61715-091Eye Itch ReliefEye Itch Relief
    62011-0232eye itch reliefeye itch relief
    69842-275Eye Itch ReliefEye Itch Relief
    70000-0522Eye Itch ReliefEye Itch Relief
    24208-601AlawayKetotifen Fumarate
    24208-600Alaway Preservative Freeketotifen fumarate
    11822-5533Eye Itch ReleifKetotifen Fumarate
    0179-8601Ketotifen FumarateKetotifen Fumarate
    0363-9060Ketotifen FumarateKetotifen Fumarate
    0536-1222Ketotifen FumarateKetotifen Fumarate
    0536-1252Ketotifen FumarateKetotifen Fumarate
    17478-717Ketotifen FumarateKetotifen 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.