NDC 61919-490

FLUOXETINE HCL

Fluoxetine

FLUOXETINE HCL is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Directrx. The primary component is Fluoxetine Hydrochloride.

Product ID61919-490_26010f0c-4cce-5d74-e054-00144ff88e88
NDC61919-490
Product TypeHuman Prescription Drug
Proprietary NameFLUOXETINE HCL
Generic NameFluoxetine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2015-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA076990
Labeler NameDirectRX
Substance NameFLUOXETINE HYDROCHLORIDE
Active Ingredient Strength40 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-490-30

30 CAPSULE in 1 BOTTLE (61919-490-30)
Marketing Start Date2015-12-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-490-90 [61919049090]

FLUOXETINE HCL CAPSULE
Marketing CategoryANDA
Application NumberANDA076990
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-01

NDC 61919-490-30 [61919049030]

FLUOXETINE HCL CAPSULE
Marketing CategoryANDA
Application NumberANDA076990
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-03

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE40 mg/1

OpenFDA Data

SPL SET ID:62e08a06-2f62-42aa-828f-5c2d1415657e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313989

    • Pharmacological Class

    • Serotonin Reuptake Inhibitor [EPC]
    • Serotonin Uptake Inhibitors [MoA]

    NDC Crossover Matching brand name "FLUOXETINE HCL" or generic name "Fluoxetine"

    NDCBrand NameGeneric Name
    49909-005Fluoxetine HClFluoxetine HCl
    52427-576Fluoxetine HClFluoxetine HCl
    61919-490FLUOXETINE HCLFLUOXETINE HCL
    0093-0807FluoxetineFluoxetine
    0093-5262FluoxetineFluoxetine
    0093-7188FluoxetineFluoxetine
    0093-7198FluoxetineFluoxetine
    0378-0734Fluoxetinefluoxetine
    0378-0735Fluoxetinefluoxetine
    0615-7625FluoxetineFluoxetine
    0615-7638FluoxetineFluoxetine
    0615-8093FluoxetineFluoxetine
    0904-5784FluoxetineFluoxetine
    0904-5785FluoxetineFluoxetine
    0615-5501Fluoxetine HydrochlorideFluoxetine
    0615-5502Fluoxetine HydrochlorideFluoxetine
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.