NDC 49252-009

duloxetine

Duloxetine

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

Product ID49252-009_1902e3e6-2ffb-4ffb-9aab-268ca6a4b776
NDC49252-009
Product TypeHuman Prescription Drug
Proprietary Nameduloxetine
Generic NameDuloxetine
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2015-12-05
Marketing CategoryANDA / ANDA
Application NumberANDA202336
Labeler NameInventia Healthcare Private Limited
Substance NameDULOXETINE HYDROCHLORIDE
Active Ingredient Strength60 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 49252-009-10

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-009-10)
Marketing Start Date2015-12-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49252-009-18 [49252000918]

duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202336
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-05
Inactivation Date2020-01-31

NDC 49252-009-10 [49252000910]

duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202336
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-05
Inactivation Date2020-01-31

NDC 49252-009-12 [49252000912]

duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202336
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-05
Inactivation Date2020-01-31

NDC 49252-009-11 [49252000911]

duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202336
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-05
Inactivation Date2020-01-31

NDC 49252-009-57 [49252000957]

duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202336
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-05
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:eab90059-ea1c-46c1-884d-c15e7c562a01
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 596930
  • 596934
  • 596926
    • UPC Code
  • 0349252008113
  • 0349252009103
  • 0349252007109

    • 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
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