NDC 71610-028

Fluoxetine

Fluoxetine

Fluoxetine is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Fluoxetine Hydrochloride.

Product ID71610-028_2bf72f3c-3456-42f0-b464-c5e5a97da084
NDC71610-028
Product TypeHuman Prescription Drug
Proprietary NameFluoxetine
Generic NameFluoxetine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2017-08-14
Marketing CategoryANDA / ANDA
Application NumberANDA076001
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameFLUOXETINE HYDROCHLORIDE
Active Ingredient Strength20 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 71610-028-53

60 CAPSULE in 1 BOTTLE (71610-028-53)
Marketing Start Date2018-01-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71610-028-30 [71610002830]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA076001
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-01-12

NDC 71610-028-70 [71610002870]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA076001
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-01-12

NDC 71610-028-80 [71610002880]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA076001
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-01-12

NDC 71610-028-53 [71610002853]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA076001
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-01-12

NDC 71610-028-60 [71610002860]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA076001
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-01-12

NDC 71610-028-92 [71610002892]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA076001
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-01-26

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:a298f270-67c9-42cc-9089-6a1e3c3149b3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310385

    • 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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