NDC 13668-443

Fluoxetine

Fluoxetine

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

Product ID13668-443_947fe43f-7802-ee0b-e053-2a95a90ace5a
NDC13668-443
Product TypeHuman Prescription Drug
Proprietary NameFluoxetine
Generic NameFluoxetine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-10-21
Marketing CategoryANDA / ANDA
Application NumberANDA206937
Labeler NameTORRENT PHARMACEUTICALS LIMITED
Substance NameFLUOXETINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 13668-443-01

100 TABLET in 1 BOTTLE (13668-443-01)
Marketing Start Date2016-10-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13668-443-74 [13668044374]

Fluoxetine TABLET
Marketing CategoryANDA
Application NumberANDA206937
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-21

NDC 13668-443-30 [13668044330]

Fluoxetine TABLET
Marketing CategoryANDA
Application NumberANDA206937
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-21

NDC 13668-443-91 [13668044391]

Fluoxetine TABLET
Marketing CategoryANDA
Application NumberANDA206937
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-21

NDC 13668-443-10 [13668044310]

Fluoxetine TABLET
Marketing CategoryANDA
Application NumberANDA206937
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-21

NDC 13668-443-01 [13668044301]

Fluoxetine TABLET
Marketing CategoryANDA
Application NumberANDA206937
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-21

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:dcebc7cf-6f95-4f7a-a22b-c7d2e0f04d74
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 248642
  • 313990

    • Pharmacological Class

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

    Medicade Reported Pricing

    13668044391 FLUOXETINE HCL 10 MG TABLET

    Pricing Unit: EA | Drug Type:

    13668044330 FLUOXETINE HCL 10 MG TABLET

    Pricing Unit: EA | Drug Type:

    13668044301 FLUOXETINE HCL 10 MG TABLET

    Pricing Unit: EA | Drug Type:

    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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