NDC 71209-041

Fluoxetine

Fluoxetine

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

Product ID71209-041_2627ced2-2b0b-4d4a-8efd-92c8877d3b96
NDC71209-041
Product TypeHuman Prescription Drug
Proprietary NameFluoxetine
Generic NameFluoxetine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2019-02-21
Marketing CategoryANDA / ANDA
Application NumberANDA206993
Labeler NameCadila Pharmaceuticals Limited
Substance NameFLUOXETINE HYDROCHLORIDE
Active Ingredient Strength20 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 71209-041-01

30 CAPSULE in 1 BOTTLE (71209-041-01)
Marketing Start Date2019-02-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71209-041-10 [71209004110]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA206993
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-18

NDC 71209-041-05 [71209004105]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA206993
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-21

NDC 71209-041-11 [71209004111]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA206993
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-18

NDC 71209-041-01 [71209004101]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA206993
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-21

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:9651816f-58f5-4bf8-8183-6f3d84d36b5c
Manufacturer
UNII
UPC Code
  • 0371209042017
  • 0371209041058
  • 0371209040051

    • 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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