NDC 0121-4721

Fluoxetine

Fluoxetine Hydrochloride

Fluoxetine is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Pharmaceutical Associates, Inc.. The primary component is Fluoxetine Hydrochloride.

Product ID0121-4721_517b83d8-454f-166c-e054-00144ff88e88
NDC0121-4721
Product TypeHuman Prescription Drug
Proprietary NameFluoxetine
Generic NameFluoxetine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2002-02-01
Marketing CategoryANDA / ANDA
Application NumberANDA076015
Labeler NamePharmaceutical Associates, Inc.
Substance NameFLUOXETINE HYDROCHLORIDE
Active Ingredient Strength20 mg/5mL
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0121-4721-40

4 TRAY in 1 CASE (0121-4721-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-4721-05)
Marketing Start Date2002-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0121-4721-40 [00121472140]

Fluoxetine SOLUTION
Marketing CategoryANDA
Application NumberANDA076015
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2002-02-01

NDC 0121-4721-05 [00121472105]

Fluoxetine SOLUTION
Marketing CategoryANDA
Application NumberANDA076015
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2002-02-01

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE20 mg/5mL

OpenFDA Data

SPL SET ID:180a07fd-1f6a-4617-b8e0-f938c65ba273
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310386
    • UPC Code
  • 0301210721045

    • Pharmacological Class

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