NDC 65862-192

Fluoxetine

Fluoxetine Hydrochloride

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

Product ID65862-192_4cb04dd3-0841-4198-9dc4-f61c2c361e5d
NDC65862-192
Product TypeHuman Prescription Drug
Proprietary NameFluoxetine
Generic NameFluoxetine Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2008-01-31
Marketing CategoryANDA / DRUG FOR FURTHER PROCESSING
Application NumberANDA078619
Labeler NameAurobindo Pharma Limited
Substance NameFLUOXETINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 65862-192-01

100 CAPSULE in 1 BOTTLE (65862-192-01)
Marketing Start Date2018-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-192-26 [65862019226]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA078619
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-01-31
Marketing End Date2012-03-14

NDC 65862-192-05 [65862019205]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA078619
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-01-31

NDC 65862-192-01 [65862019201]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA078619
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-01-31

NDC 65862-192-99 [65862019299]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA078619
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-01-31

NDC 65862-192-30 [65862019230]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA078619
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-31

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE10 mg/1

Medicade Reported Pricing

65862019299 FLUOXETINE HCL 10 MG CAPSULE

Pricing Unit: EA | Drug Type:

65862019205 FLUOXETINE HCL 10 MG CAPSULE

Pricing Unit: EA | Drug Type:

65862019201 FLUOXETINE HCL 10 MG CAPSULE

Pricing Unit: EA | Drug Type:

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
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.