NDC 46708-278

DULOXETINE HYDROCHLORIDE

Duloxetine

DULOXETINE HYDROCHLORIDE 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 ID46708-278_05a744a5-64ef-42d7-a19c-568be5a272d4
NDC46708-278
Product TypeHuman Prescription Drug
Proprietary NameDULOXETINE HYDROCHLORIDE
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 Strength20 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 46708-278-10

100 CAPSULE, DELAYED RELEASE in 1 CARTON (46708-278-10)
Marketing Start Date2014-06-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46708-278-60 [46708027860]

DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202949
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-09

NDC 46708-278-30 [46708027830]

DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202949
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-09

NDC 46708-278-91 [46708027891]

DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202949
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-09

NDC 46708-278-10 [46708027810]

DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202949
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-09

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:05a744a5-64ef-42d7-a19c-568be5a272d4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 596930
  • 596934
  • 596926
    • UPC Code
  • 0346708279301
  • 0346708278304

    • 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]

    NDC Crossover Matching brand name "DULOXETINE HYDROCHLORIDE" or generic name "Duloxetine"

    NDCBrand NameGeneric Name
    0615-7894Duloxetine hydrochlorideDuloxetin hydrochloride
    0615-7895Duloxetine hydrochlorideDuloxetin hydrochloride
    68788-9370Duloxetine HydrochlorideDuloxetine Hydrochloride
    68788-9371Duloxetine HydrochlorideDuloxetine Hydrochloride
    70518-0716Duloxetine HydrochlorideDuloxetine Hydrochloride
    70518-0363Duloxetine hydrochlorideDuloxetine hydrochloride
    70518-0686Duloxetine HydrochlorideDuloxetine Hydrochloride
    70518-1273Duloxetine hydrochlorideDuloxetine hydrochloride
    70518-1272Duloxetine hydrochlorideDuloxetine hydrochloride
    0615-8034Duloxetine HydrochlorideDuloxetine Hydrochloride
    0615-8035Duloxetine HydrochlorideDuloxetine Hydrochloride
    0615-8204Duloxetine hydrochlorideDuloxetine hydrochloride
    0615-8203Duloxetine hydrochlorideDuloxetine hydrochloride
    0904-6453Duloxetine HydrochlorideDuloxetine Hydrochloride
    0904-6452Duloxetine HydrochlorideDuloxetine Hydrochloride
    0904-6454Duloxetine HydrochlorideDuloxetine Hydrochloride
    13668-110Duloxetine hydrochlorideDuloxetine hydrochloride
    13668-109Duloxetine hydrochlorideDuloxetine hydrochloride
    13668-111Duloxetine hydrochlorideDuloxetine hydrochloride
    33342-162Duloxetine HydrochlorideDuloxetine Hydrochloride
    33342-160Duloxetine HydrochlorideDuloxetine Hydrochloride
    33342-161Duloxetine HydrochlorideDuloxetine Hydrochloride
    50090-3317Duloxetine HydrochlorideDuloxetine Hydrochloride
    50436-2996Duloxetine HydrochlorideDuloxetine Hydrochloride
    50436-2997Duloxetine HydrochlorideDuloxetine Hydrochloride
    50436-0018Duloxetine HydrochlorideDuloxetine Hydrochloride
    55154-7878Duloxetine HydrochlorideDuloxetine Hydrochloride
    55700-165Duloxetine HydrochlorideDuloxetine Hydrochloride
    55700-160Duloxetine HydrochlorideDuloxetine Hydrochloride
    55700-435Duloxetine HydrochlorideDuloxetine Hydrochloride
    60505-2997Duloxetine HydrochlorideDuloxetine Hydrochloride
    60505-2996Duloxetine HydrochlorideDuloxetine Hydrochloride
    60505-2995Duloxetine HydrochlorideDuloxetine Hydrochloride
    61919-042DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDE
    61919-482DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDE
    63187-181Duloxetine HydrochlorideDuloxetine Hydrochloride
    63187-457Duloxetine hydrochlorideDuloxetine hydrochloride
    63187-172Duloxetine HydrochlorideDuloxetine Hydrochloride
    63187-716Duloxetine HydrochlorideDuloxetine Hydrochloride
    64725-1100Duloxetine hydrochlorideDuloxetine hydrochloride
    55154-7889Duloxetine HydrochlorideDuloxetine Hydrochloride
    0615-8290Duloxetine hydrochlorideDuloxetine hydrochloride
    0002-3235CymbaltaDuloxetine hydrochloride
    0002-3240CymbaltaDuloxetine hydrochloride
    0002-3270CymbaltaDuloxetine hydrochloride
    0093-7542DuloxetineDuloxetine
    0093-7543DuloxetineDuloxetine
    0093-7544DuloxetineDuloxetine
    0228-2890DuloxetineDuloxetine
    0228-2891DuloxetineDuloxetine
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