NDC 61919-482

DULOXETINE HYDROCHLORIDE

Duloxetine Hydrochloride

DULOXETINE HYDROCHLORIDE is a Oral Capsule, Delayed Release Pellets in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Duloxetine Hydrochloride.

Product ID61919-482_3710dd6f-4689-288b-e054-00144ff8d46c
NDC61919-482
Product TypeHuman Prescription Drug
Proprietary NameDULOXETINE HYDROCHLORIDE
Generic NameDuloxetine Hydrochloride
Dosage FormCapsule, Delayed Release Pellets
Route of AdministrationORAL
Marketing Start Date2014-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA203088
Labeler NameDIRECT RX
Substance NameDULOXETINE HYDROCHLORIDE
Active Ingredient Strength30 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 61919-482-90

90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (61919-482-90)
Marketing Start Date2019-08-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-482-90 [61919048290]

DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-16

NDC 61919-482-60 [61919048260]

DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-05-19
Inactivation Date2020-01-31

NDC 61919-482-30 [61919048230]

DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-05-19
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE30 mg/1

OpenFDA Data

SPL SET ID:b07dc470-5899-40e8-9af2-559ddc75a4be
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 596930
  • Pharmacological Class

    • 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 Hydrochloride"

    NDCBrand NameGeneric Name
    0615-7894Duloxetine hydrochlorideDuloxetin hydrochloride
    0615-7895Duloxetine hydrochlorideDuloxetin hydrochloride
    0615-8034Duloxetine HydrochlorideDuloxetine Hydrochloride
    0615-8035Duloxetine HydrochlorideDuloxetine Hydrochloride
    0615-8203Duloxetine hydrochlorideDuloxetin hydrochloride
    0615-8204Duloxetine hydrochlorideDuloxetin hydrochloride
    0615-8290Duloxetine hydrochlorideDuloxetin hydrochloride
    0904-6452Duloxetine HydrochlorideDuloxetine Hydrochloride
    0904-6453Duloxetine HydrochlorideDuloxetine Hydrochloride
    0904-6454Duloxetine HydrochlorideDuloxetine 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
    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
    0002-3235CymbaltaDuloxetine hydrochloride
    0002-3240CymbaltaDuloxetine hydrochloride
    0002-3270CymbaltaDuloxetine hydrochloride

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