NDC 68788-9371

Duloxetine Hydrochloride

Duloxetine Hydrochloride

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

Product ID68788-9371_14e985ee-fe54-4a9c-8ef0-3a5f88fcacbf
NDC68788-9371
Product TypeHuman Prescription Drug
Proprietary NameDuloxetine Hydrochloride
Generic NameDuloxetine Hydrochloride
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2014-08-20
Marketing CategoryANDA / ANDA
Application NumberANDA202045
Labeler NamePreferred Pharmaceuticals, Inc.
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 Through2019-12-31

Packaging

NDC 68788-9371-3

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-9371-3)
Marketing Start Date2014-08-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-9371-0 [68788937100]

Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202045
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-08-20
Marketing End Date2020-05-07

NDC 68788-9371-2 [68788937102]

Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202045
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-08-20
Marketing End Date2020-05-07

NDC 68788-9371-6 [68788937106]

Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202045
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-08-20
Marketing End Date2020-05-07

NDC 68788-9371-3 [68788937103]

Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202045
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-08-20
Marketing End Date2020-05-07

NDC 68788-9371-1 [68788937101]

Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202045
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-08-20
Marketing End Date2020-05-07

NDC 68788-9371-9 [68788937109]

Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202045
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-08-20
Marketing End Date2020-05-07

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:cd26d57b-a229-4990-bfcc-8e7cbad16dda
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 596930
  • 596926

    • 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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