NDC 68071-4314

Fluoxetine

Fluoxetine Hydrochloride

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

Product ID68071-4314_7baad2e5-5c10-127d-e053-2a91aa0a2241
NDC68071-4314
Product TypeHuman Prescription Drug
Proprietary NameFluoxetine
Generic NameFluoxetine Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2015-03-16
Marketing CategoryANDA / ANDA
Application NumberANDA204597
Labeler NameNuCare Pharmaceuticals,Inc.
Substance NameFLUOXETINE HYDROCHLORIDE
Active Ingredient Strength20 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68071-4314-1

15 CAPSULE in 1 BOTTLE (68071-4314-1)
Marketing Start Date2018-03-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-4314-6 [68071431406]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA204597
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-07

NDC 68071-4314-5 [68071431405]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA204597
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-07

NDC 68071-4314-9 [68071431409]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA204597
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-07

NDC 68071-4314-3 [68071431403]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA204597
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-07

NDC 68071-4314-1 [68071431401]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA204597
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-07

NDC 68071-4314-2 [68071431402]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA204597
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-07

NDC 68071-4314-8 [68071431408]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA204597
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-07

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:66d6664c-c523-e3c4-e053-2991aa0a1258
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310385

    • 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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