NDC 70934-141

Fluoxetine Hydrochloride

Fluoxetine Hydrochloride

Fluoxetine Hydrochloride is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Denton Pharma, Inc. Dba Northwind Pharmaceuticals. The primary component is Fluoxetine Hydrochloride.

Product ID70934-141_73a3b6f5-55cf-0f46-e053-2a91aa0a34e0
NDC70934-141
Product TypeHuman Prescription Drug
Proprietary NameFluoxetine Hydrochloride
Generic NameFluoxetine Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-06-27
Marketing CategoryANDA / ANDA
Application NumberANDA075049
Labeler NameDenton Pharma, Inc. DBA Northwind Pharmaceuticals
Substance NameFLUOXETINE HYDROCHLORIDE
Active Ingredient Strength20 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70934-141-30

30 CAPSULE in 1 BOTTLE, PLASTIC (70934-141-30)
Marketing Start Date2018-06-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70934-141-30 [70934014130]

Fluoxetine Hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA075049
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-27

NDC 70934-141-90 [70934014190]

Fluoxetine Hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA075049
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-30

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:73a3b6f5-55ce-0f46-e053-2a91aa0a34e0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310385

    • Pharmacological Class

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