NDC 50228-422

Fluoxetine

Fluoxetine Hydrochloride

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

Product ID50228-422_39b916dc-598b-489f-9669-b9e67166e5bb
NDC50228-422
Product TypeHuman Prescription Drug
Proprietary NameFluoxetine
Generic NameFluoxetine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-01-10
Marketing CategoryANDA / ANDA
Application NumberANDA211282
Labeler NameScieGen Pharmaceuticals, Inc.
Substance NameFLUOXETINE HYDROCHLORIDE
Active Ingredient Strength60 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50228-422-10

1000 TABLET in 1 BOTTLE (50228-422-10)
Marketing Start Date2019-01-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50228-422-30 [50228042230]

Fluoxetine TABLET
Marketing CategoryANDA
Application NumberANDA211282
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-10

NDC 50228-422-10 [50228042210]

Fluoxetine TABLET
Marketing CategoryANDA
Application NumberANDA211282
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-10

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:a7ba9184-7dad-4f82-a947-bb2cc6b760ce
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1190110
    • UPC Code
  • 0350228422307
  • 0350228422109

    • 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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