NDC 68788-6790

FLUOXETINE

Fluoxetine

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

Product ID68788-6790_6d74f521-95c2-4726-9a5f-5945ed6ab12d
NDC68788-6790
Product TypeHuman Prescription Drug
Proprietary NameFLUOXETINE
Generic NameFluoxetine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2016-11-02
Marketing CategoryANDA / ANDA
Application NumberANDA204597
Labeler NamePreferred 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 68788-6790-6

60 CAPSULE in 1 BOTTLE (68788-6790-6)
Marketing Start Date2016-11-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-6790-6 [68788679006]

FLUOXETINE CAPSULE
Marketing CategoryANDA
Application NumberANDA204597
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-02
Marketing End Date2020-05-27

NDC 68788-6790-9 [68788679009]

FLUOXETINE CAPSULE
Marketing CategoryANDA
Application NumberANDA204597
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-02
Marketing End Date2020-05-27

NDC 68788-6790-3 [68788679003]

FLUOXETINE CAPSULE
Marketing CategoryANDA
Application NumberANDA204597
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-02
Marketing End Date2020-05-27

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE40 mg/1

OpenFDA Data

SPL SET ID:2ee1f732-7cf6-4757-8048-523fc2ef6f55
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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.