NDC 43547-380

DULOXETINE

Duloxetine

DULOXETINE is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Solco Healthcare Us, Llc. The primary component is Duloxetine Hydrochloride.

Product ID43547-380_1687aea0-978e-4fd3-a299-1f6121fc9523
NDC43547-380
Product TypeHuman Prescription Drug
Proprietary NameDULOXETINE
Generic NameDuloxetine
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2016-01-20
Marketing CategoryANDA / ANDA
Application NumberANDA206653
Labeler NameSolco Healthcare US, LLC
Substance NameDULOXETINE HYDROCHLORIDE
Active Ingredient Strength30 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 43547-380-03

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-380-03)
Marketing Start Date2016-01-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43547-380-03 [43547038003]

DULOXETINE CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA206653
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-01-20

NDC 43547-380-11 [43547038011]

DULOXETINE CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA206653
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-01-20

NDC 43547-380-09 [43547038009]

DULOXETINE CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA206653
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-01-20

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE30 mg/1

OpenFDA Data

SPL SET ID:a105a648-6a97-4151-b9de-d7eac90a8f79
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 596930
  • 596934
  • 596926
  • Pharmacological Class

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

    Medicade Reported Pricing

    43547038011 DULOXETINE HCL DR 30 MG CAP

    Pricing Unit: EA | Drug Type:

    43547038009 DULOXETINE HCL DR 30 MG CAP

    Pricing Unit: EA | Drug Type:

    43547038003 DULOXETINE HCL DR 30 MG CAP

    Pricing Unit: EA | Drug Type:

    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

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