NDC 63629-5202

Duloxetine

Duloxetine

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

Product ID63629-5202_5d2b82ea-1e64-49e2-92ac-91c3dff3de94
NDC63629-5202
Product TypeHuman Prescription Drug
Proprietary NameDuloxetine
Generic NameDuloxetine
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2013-12-11
Marketing CategoryANDA / ANDA
Application NumberANDA090745
Labeler NameBryant Ranch Prepack
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 Through2017-12-31

Packaging

NDC 63629-5202-1

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-5202-1)
Marketing Start Date2014-01-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-5202-2 [63629520202]

Duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090745
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-12-11
Inactivation Date2019-11-27

NDC 63629-5202-1 [63629520201]

Duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090745
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-12-11
Inactivation Date2019-11-27

NDC 63629-5202-3 [63629520203]

Duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090745
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-12-11
Inactivation Date2019-11-27

NDC 63629-5202-4 [63629520204]

Duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090745
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-12-11
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:fe3e2db6-1aee-4767-bc1f-8547bac4b41a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 596934

    • 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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