NDC 65841-801

Duloxetine

Duloxetine

Duloxetine is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Zydus Lifesciences Limited. The primary component is Duloxetine Hydrochloride.

Product ID65841-801_55d15483-b1dd-4901-ae80-e8892bd25e3a
NDC65841-801
Product TypeHuman Prescription Drug
Proprietary NameDuloxetine
Generic NameDuloxetine
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2014-05-27
Marketing CategoryANDA / ANDA
Application NumberANDA090739
Labeler NameZydus Lifesciences Limited
Substance NameDULOXETINE HYDROCHLORIDE
Active Ingredient Strength60 mg/1
Pharm ClassesNorepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 65841-801-06

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-801-06)
Marketing Start Date2014-05-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65841-801-06 [65841080106]

Duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090739
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-05-27

NDC 65841-801-16 [65841080116]

Duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090739
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-05-27

NDC 65841-801-10 [65841080110]

Duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090739
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-05-27

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:f36b414e-ace4-4f04-a80f-75bb25db430d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 596930
  • 596934
  • 596926
    • UPC Code
  • 0365841801163
  • 0365841800166
  • 0365841799163

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Duloxetine" or generic name "Duloxetine"

    NDCBrand NameGeneric Name
    0093-7542DuloxetineDuloxetine
    0093-7543DuloxetineDuloxetine
    0093-7544DuloxetineDuloxetine
    0228-2890DuloxetineDuloxetine
    0228-2891DuloxetineDuloxetine
    0228-2892DuloxetineDuloxetine
    0904-7043DuloxetineDuloxetine Hydrochloride
    0904-7044DuloxetineDuloxetine Hydrochloride
    0904-7045DuloxetineDuloxetine Hydrochloride
    23155-654duloxetineduloxetine
    23155-655duloxetineduloxetine
    23155-656duloxetineduloxetine
    25000-608DuloxetineDuloxetine Hydrochloride
    25000-609DuloxetineDuloxetine Hydrochloride
    25000-610DuloxetineDuloxetine Hydrochloride
    27241-097DuloxetineDuloxetine
    27241-098DuloxetineDuloxetine
    67877-264DuloxetineDuloxetine
    67877-265DuloxetineDuloxetine
    67877-263DuloxetineDuloxetine
    68001-255DuloxetineDuloxetine
    68001-256DuloxetineDuloxetine
    68001-257DuloxetineDuloxetine
    68071-4700DuloxetineDuloxetine
    68084-692DuloxetineDuloxetine
    68084-675DuloxetineDuloxetine
    68084-683DuloxetineDuloxetine
    68151-4727DuloxetineDuloxetine
    68180-294DuloxetineDuloxetine
    68180-297DuloxetineDuloxetine
    68180-295DuloxetineDuloxetine
    68180-296DuloxetineDuloxetine
    68382-385DuloxetineDuloxetine
    68382-386DuloxetineDuloxetine
    68382-387DuloxetineDuloxetine
    68788-6427duloxetineduloxetine
    68788-9262DuloxetineDuloxetine
    68788-9266DuloxetineDuloxetine
    69097-298duloxetineduloxetine
    69097-297duloxetineduloxetine
    69097-299duloxetineduloxetine
    70518-0491DuloxetineDuloxetine
    70518-1066DuloxetineDuloxetine
    70518-0937DuloxetineDuloxetine
    70518-1054DuloxetineDuloxetine
    70518-1139DuloxetineDuloxetine
    70518-0685DuloxetineDuloxetine
    70518-1128DULOXETINEDULOXETINE
    70518-1011DuloxetineDuloxetine
    70518-1244DuloxetineDuloxetine
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.