NDC 66267-587

FLUOXETINE

Fluoxetine

FLUOXETINE is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Nucarepharmaceuticals, Inc.. The primary component is Fluoxetine Hydrochloride.

Product ID66267-587_50490db4-9711-6d7e-e054-00144ff88e88
NDC66267-587
Product TypeHuman Prescription Drug
Proprietary NameFLUOXETINE
Generic NameFluoxetine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2015-07-30
Marketing CategoryANDA / ANDA
Application NumberANDA204597
Labeler NameNuCarePharmaceuticals, Inc.
Substance NameFLUOXETINE HYDROCHLORIDE
Active Ingredient Strength40 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 66267-587-90

90 CAPSULE in 1 BOTTLE (66267-587-90)
Marketing Start Date2017-05-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66267-587-90 [66267058790]

FLUOXETINE CAPSULE
Marketing CategoryANDA
Application NumberANDA204597
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-24
Marketing End Date2018-12-31

NDC 66267-587-30 [66267058730]

FLUOXETINE CAPSULE
Marketing CategoryANDA
Application NumberANDA204597
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-05-24
Marketing End Date2018-12-31

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE40 mg/1

OpenFDA Data

SPL SET ID:50490db4-9710-6d7e-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313989

    • Pharmacological Class

    • Serotonin Reuptake Inhibitor [EPC]
    • Serotonin Uptake Inhibitors [MoA]

    NDC Crossover Matching brand name "FLUOXETINE" or generic name "Fluoxetine"

    NDCBrand NameGeneric Name
    0093-0807FluoxetineFluoxetine
    0093-5262FluoxetineFluoxetine
    0093-7188FluoxetineFluoxetine
    0093-7198FluoxetineFluoxetine
    0121-0721FluoxetineFLUOXETINE HYDROCHLORIDE
    0121-4721FluoxetineFLUOXETINE HYDROCHLORIDE
    0378-0734Fluoxetinefluoxetine
    0378-0735Fluoxetinefluoxetine
    0615-1357fluoxetinefluoxetine hydrochloride
    0615-1384FluoxetineFluoxetine Hydrochloride
    68001-129FluoxetineFluoxetine
    68071-3130FluoxetineFluoxetine
    68071-3133FluoxetineFluoxetine
    68071-3318FluoxetineFluoxetine
    68071-3367FluoxetineFluoxetine
    68071-3110FLUOXETINEFLUOXETINE
    68071-3284FluoxetineFluoxetine
    68071-4033FluoxetineFluoxetine
    68071-4314FluoxetineFluoxetine
    68071-4043FluoxetineFluoxetine
    68071-4606FluoxetineFluoxetine
    68071-4653FluoxetineFluoxetine
    68071-4671FluoxetineFluoxetine
    68071-4542FluoxetineFluoxetine
    68084-101FluoxetineFluoxetine
    68084-605FluoxetineFluoxetine
    68645-130FluoxetineFluoxetine
    68645-131FluoxetineFluoxetine
    68788-6790FLUOXETINEFLUOXETINE
    68788-9223FluoxetineFluoxetine
    68788-6794FLUOXETINEFLUOXETINE
    68788-7356FluoxetineFluoxetine
    68788-7409FluoxetineFluoxetine
    68788-9222FluoxetineFluoxetine
    70518-0262FLUOXETINEFLUOXETINE
    70518-0032FLUOXETINEFLUOXETINE
    70518-0369FluoxetineFluoxetine
    70518-0417FluoxetineFluoxetine
    70518-0997FluoxetineFluoxetine
    70518-1174FluoxetineFluoxetine
    70518-0971FluoxetineFluoxetine
    70518-1432FluoxetineFluoxetine
    70518-1321FluoxetineFluoxetine
    70518-1775FluoxetineFluoxetine
    70518-1359FluoxetineFluoxetine
    70518-1619FluoxetineFluoxetine
    70518-1757FluoxetineFluoxetine
    70518-1987FluoxetineFluoxetine
    70934-077FluoxetineFluoxetine
    71205-178FluoxetineFluoxetine
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