NDC 71335-0565

Fluoxetine

Fluoxetine

Fluoxetine is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Fluoxetine Hydrochloride.

Product ID71335-0565_358089af-170e-428d-92c4-beb1f805a381
NDC71335-0565
Product TypeHuman Prescription Drug
Proprietary NameFluoxetine
Generic NameFluoxetine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2016-01-29
Marketing CategoryANDA / ANDA
Application NumberANDA090223
Labeler NameBryant Ranch Prepack
Substance NameFLUOXETINE HYDROCHLORIDE
Active Ingredient Strength40 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 71335-0565-1

30 CAPSULE in 1 BOTTLE (71335-0565-1)
Marketing Start Date2017-02-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0565-3 [71335056503]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA090223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-27

NDC 71335-0565-4 [71335056504]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA090223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-27

NDC 71335-0565-6 [71335056506]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA090223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-27

NDC 71335-0565-7 [71335056507]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA090223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-27

NDC 71335-0565-5 [71335056505]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA090223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-27

NDC 71335-0565-2 [71335056502]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA090223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-27

NDC 71335-0565-1 [71335056501]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA090223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-27

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE40 mg/1

OpenFDA Data

SPL SET ID:d1cdecb8-cd14-490f-862f-dcff21417d64
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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