NDC 49483-701

Fluoxetine

Fluoxetine Hydrochloride

Fluoxetine is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Time Cap Laboratories, Inc.. The primary component is Fluoxetine Hydrochloride.

Product ID49483-701_d7a4db7f-cdad-2b36-e053-2995a90a8d64
NDC49483-701
Product TypeHuman Prescription Drug
Proprietary NameFluoxetine
Generic NameFluoxetine Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2022-02-12
Marketing CategoryANDA /
Application NumberANDA075465
Labeler NameTIME CAP LABORATORIES, INC.
Substance NameFLUOXETINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 49483-701-01

100 CAPSULE in 1 BOTTLE (49483-701-01)
Marketing Start Date2022-02-12
NDC Exclude FlagN
Sample Package?N

Drug Details

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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