NDC 71800-011

Duloxetine Hydrochloride Delayed Release

Duloxetine Hydrochloride

Duloxetine Hydrochloride Delayed Release is a Oral Capsule, Delayed Release Pellets in the Human Prescription Drug category. It is labeled and distributed by Innovida Pharmaceutique Corporation. The primary component is Duloxetine Hydrochloride.

Product ID71800-011_f4dc490f-a45b-4b23-9978-fac6e7790d86
NDC71800-011
Product TypeHuman Prescription Drug
Proprietary NameDuloxetine Hydrochloride Delayed Release
Generic NameDuloxetine Hydrochloride
Dosage FormCapsule, Delayed Release Pellets
Route of AdministrationORAL
Marketing Start Date2018-04-21
Marketing CategoryANDA / ANDA
Application NumberANDA203088
Labeler NameInnovida Pharmaceutique Corporation
Substance NameDULOXETINE HYDROCHLORIDE
Active Ingredient Strength40 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 71800-011-30

30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71800-011-30)
Marketing Start Date2019-03-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71800-011-30 [71800001130]

Duloxetine Hydrochloride Delayed Release CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-06

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE40 mg/1

OpenFDA Data

SPL SET ID:8f9d39aa-9d3b-461f-a74a-71a0f936b57e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 616402

    • 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 Delayed Release" or generic name "Duloxetine Hydrochloride"

    NDCBrand NameGeneric Name
    71800-011Duloxetine Hydrochloride Delayed ReleaseDuloxetine Hydrochloride Delayed Release
    0002-3235CymbaltaDuloxetine hydrochloride
    0002-3240CymbaltaDuloxetine hydrochloride
    0002-3270CymbaltaDuloxetine hydrochloride
    21695-145CymbaltaDuloxetine hydrochloride
    21695-146CymbaltaDuloxetine hydrochloride
    0904-7043DuloxetineDuloxetine Hydrochloride
    0904-7044DuloxetineDuloxetine Hydrochloride
    0904-7045DuloxetineDuloxetine Hydrochloride
    0615-8034Duloxetine HydrochlorideDuloxetine Hydrochloride
    0615-8035Duloxetine HydrochlorideDuloxetine Hydrochloride
    0904-6452Duloxetine HydrochlorideDuloxetine Hydrochloride
    0904-6453Duloxetine HydrochlorideDuloxetine Hydrochloride
    0904-6454Duloxetine HydrochlorideDuloxetine Hydrochloride
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