NDC 43063-197

FLUOXETINE

Fluoxetine Hydrochloride

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

Product ID43063-197_7d3af8da-fdf4-9cb2-e053-2a91aa0a8dc6
NDC43063-197
Product TypeHuman Prescription Drug
Proprietary NameFLUOXETINE
Generic NameFluoxetine Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2008-10-14
Marketing CategoryANDA / ANDA
Application NumberANDA076922
Labeler NamePD-Rx Pharmaceuticals, Inc.
Substance NameFLUOXETINE HYDROCHLORIDE
Active Ingredient Strength40 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 43063-197-30

30 CAPSULE in 1 BOTTLE, PLASTIC (43063-197-30)
Marketing Start Date2011-06-21
Marketing End Date2021-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43063-197-30 [43063019730]

FLUOXETINE CAPSULE
Marketing CategoryANDA
Application NumberANDA076922
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-21
Marketing End Date2021-10-31

NDC 43063-197-90 [43063019790]

FLUOXETINE CAPSULE
Marketing CategoryANDA
Application NumberANDA076922
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-04-14
Marketing End Date2021-10-31

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE40 mg/1

OpenFDA Data

SPL SET ID:02e761f7-24e4-4685-8fb5-0fe9cbbff8f7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313989
    • UPC Code
  • 0343063197301

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0093-0807FluoxetineFluoxetine
    0093-5262FluoxetineFluoxetine
    0093-7188FluoxetineFluoxetine
    0093-7198FluoxetineFluoxetine
    0121-0721FluoxetineFLUOXETINE HYDROCHLORIDE
    0121-4721FluoxetineFLUOXETINE HYDROCHLORIDE
    0378-0734Fluoxetinefluoxetine
    0378-0735Fluoxetinefluoxetine
    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
    0615-1384FluoxetineFluoxetine
    71205-188FluoxetineFluoxetine
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