NDC 46708-130

Duloxetine Hydrochloride 60 mg

Duloxetine

Duloxetine Hydrochloride 60 mg is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is Duloxetine Hydrochloride.

Product ID46708-130_53df64fc-7fec-4c14-8fe3-c6a128be814a
NDC46708-130
Product TypeHuman Prescription Drug
Proprietary NameDuloxetine Hydrochloride 60 mg
Generic NameDuloxetine
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2014-06-09
Marketing CategoryANDA / ANDA
Application NumberANDA202949
Labeler NameAlembic Pharmaceuticals 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 FlagN
Listing Certified Through2019-12-31

Packaging

NDC 46708-130-90

90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-130-90)
Marketing Start Date2014-06-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46708-130-90 [46708013090]

Duloxetine Hydrochloride 60 mg CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202949
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-09
Inactivation Date2020-01-31

NDC 46708-130-91 [46708013091]

Duloxetine Hydrochloride 60 mg CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202949
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-09
Inactivation Date2020-01-31

NDC 46708-130-10 [46708013010]

Duloxetine Hydrochloride 60 mg CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202949
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-09
Inactivation Date2020-01-31

NDC 46708-130-30 [46708013030]

Duloxetine Hydrochloride 60 mg CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202949
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-09
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:53df64fc-7fec-4c14-8fe3-c6a128be814a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 596930
  • 596934
  • 596926
    • UPC Code
  • 0346708128302
  • 0346708129309
  • 0346708130305

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Duloxetine Hydrochloride 60 mg" or generic name "Duloxetine"

    NDCBrand NameGeneric Name
    46708-130Duloxetine Hydrochloride 60 mgDuloxetine Hydrochloride 60 mg
    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
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