NDC 0093-0807

Fluoxetine

Fluoxetine

Fluoxetine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Fluoxetine Hydrochloride.

Product ID0093-0807_121a1b98-a764-487d-8046-6d0d296e3f47
NDC0093-0807
Product TypeHuman Prescription Drug
Proprietary NameFluoxetine
Generic NameFluoxetine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-04-05
Marketing CategoryANDA / ANDA
Application NumberANDA075872
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameFLUOXETINE HYDROCHLORIDE
Active Ingredient Strength20 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0093-0807-01

100 TABLET, FILM COATED in 1 BOTTLE (0093-0807-01)
Marketing Start Date2019-04-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-0807-56 [00093080756]

Fluoxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075872
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-05

NDC 0093-0807-01 [00093080701]

Fluoxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075872
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-05

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:662f3e16-bf42-4127-8e56-4eb45780e059
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313990
    • UPC Code
  • 0300937188568

    • 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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