NDC 27437-298

Irenka

Duloxetine

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

Product ID27437-298_6a2c635d-32d1-4b42-b258-b0d83305ddd9
NDC27437-298
Product TypeHuman Prescription Drug
Proprietary NameIrenka
Generic NameDuloxetine
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2015-06-01
Marketing CategoryANDA / ANDA
Application NumberANDA090694
Labeler NameLUPIN PHARMA
Substance NameDULOXETINE HYDROCHLORIDE
Active Ingredient Strength40 mg/1
Pharm ClassesNorepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 27437-298-06

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27437-298-06)
Marketing Start Date2015-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 27437-298-06 [27437029806]

Irenka CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090694
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-06-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE40 mg/1

OpenFDA Data

SPL SET ID:5e288ace-c350-4e14-8552-e2c2c563e6fe
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1652069
  • 616402
    • UPC Code
  • 0327437298061

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    27437-298IrenkaIrenka
    0093-7542DuloxetineDuloxetine
    0093-7543DuloxetineDuloxetine
    0093-7544DuloxetineDuloxetine
    0228-2890DuloxetineDuloxetine
    0228-2891DuloxetineDuloxetine
    0228-2892DuloxetineDuloxetine
    23155-654duloxetineduloxetine
    23155-655duloxetineduloxetine
    23155-656duloxetineduloxetine
    27241-097DuloxetineDuloxetine
    27241-098DuloxetineDuloxetine
    27241-099DuloxetineDuloxetine
    27241-164DuloxetineDuloxetine

    Trademark Results [Irenka]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    IRENKA
    IRENKA
    86621647 5004602 Live/Registered
    Lupin Limited
    2015-05-06
    IRENKA
    IRENKA
    85830179 not registered Dead/Abandoned
    Lupin Limited
    2013-01-23
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