NDC 47335-618

DRIZALMA SPRINKLE

Duloxetine

DRIZALMA SPRINKLE is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Duloxetine Hydrochloride.

Product ID47335-618_0c01a1fd-afc2-4c3e-9d5a-5000fa5a9339
NDC47335-618
Product TypeHuman Prescription Drug
Proprietary NameDRIZALMA SPRINKLE
Generic NameDuloxetine
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2019-08-01
Marketing CategoryNDA / NDA
Application NumberNDA212516
Labeler NameSUN PHARMACEUTICAL INDUSTRIES, INC.
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 FlagN
Listing Certified Through2020-12-31

Packaging

NDC 47335-618-10

1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-618-10)
Marketing Start Date2019-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47335-618-10 [47335061810]

DRIZALMA SPRINKLE CAPSULE, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA212516
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-01

NDC 47335-618-30 [47335061830]

DRIZALMA SPRINKLE CAPSULE, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA212516
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-01

NDC 47335-618-60 [47335061860]

DRIZALMA SPRINKLE CAPSULE, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA212516
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-01

NDC 47335-618-90 [47335061890]

DRIZALMA SPRINKLE CAPSULE, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA212516
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-01

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE40 mg/1

OpenFDA Data

SPL SET ID:b41423b8-dfec-4d79-ba3c-e43a87803d85
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 596930
  • 616402
  • 596934
  • 596926
    • UPC Code
  • 0348335619307

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    47335-618DRIZALMA SPRINKLEDRIZALMA SPRINKLE
    47335-619DRIZALMA SPRINKLEDRIZALMA SPRINKLE
    47335-616DRIZALMA SPRINKLEDRIZALMA SPRINKLE
    47335-617DRIZALMA SPRINKLEDRIZALMA SPRINKLE
    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 [DRIZALMA SPRINKLE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DRIZALMA SPRINKLE
    DRIZALMA SPRINKLE
    97779623 not registered Live/Pending
    Sun Pharmaceutical Industries Limited
    2023-02-03
    DRIZALMA SPRINKLE
    DRIZALMA SPRINKLE
    88596037 not registered Live/Pending
    Sun Pharmaceutical Industries Limited
    2019-08-28
    DRIZALMA SPRINKLE
    DRIZALMA SPRINKLE
    88219739 not registered Live/Pending
    Sun Pharmaceutical Industries Limited
    2018-12-06
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.