NDC 50228-421

Fluoxetine

Fluoxetine

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

Product ID50228-421_2942d5f5-a000-45ae-a564-0b5f9ae36116
NDC50228-421
Product TypeHuman Prescription Drug
Proprietary NameFluoxetine
Generic NameFluoxetine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-03-20
Marketing CategoryANDA / ANDA
Application NumberANDA210935
Labeler NameScieGen Pharmaceuticals, Inc
Substance NameFLUOXETINE HYDROCHLORIDE
Active Ingredient Strength20 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50228-421-01

100 TABLET, FILM COATED in 1 BOTTLE (50228-421-01)
Marketing Start Date2019-03-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50228-421-30 [50228042130]

Fluoxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210935
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-20

NDC 50228-421-01 [50228042101]

Fluoxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210935
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-20

NDC 50228-421-10 [50228042110]

Fluoxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210935
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-20

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE20 mg/1

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"

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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