NDC 58517-160

paroxetine hydrochloride

Paroxetine Hydrochloride

paroxetine hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by New Horizon Rx Group, Llc. The primary component is Paroxetine Hydrochloride Hemihydrate.

Product ID58517-160_113e0540-bfcd-4d68-b128-c5cfc1ce938e
NDC58517-160
Product TypeHuman Prescription Drug
Proprietary Nameparoxetine hydrochloride
Generic NameParoxetine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-08-25
Marketing CategoryANDA / ANDA
Application NumberANDA078902
Labeler NameNew Horizon Rx Group, LLC
Substance NamePAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active Ingredient Strength20 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 58517-160-30

30 TABLET in 1 BOTTLE (58517-160-30)
Marketing Start Date2013-08-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58517-160-30 [58517016030]

paroxetine hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA078902
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-08-25
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE20 mg/1

OpenFDA Data

SPL SET ID:08ac6383-b43c-4eb6-9ca4-43b423bf9536
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1738495
    • UPC Code
  • 0358517160305

    • Pharmacological Class

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

    Medicade Reported Pricing

    58517016030 PAROXETINE HCL 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "paroxetine hydrochloride" or generic name "Paroxetine Hydrochloride"

    NDCBrand NameGeneric Name
    0378-2003Paroxetine Hydrochlorideparoxetine hydrochloride
    0378-2004Paroxetine Hydrochlorideparoxetine hydrochloride
    0378-2005Paroxetine Hydrochlorideparoxetine hydrochloride
    70518-1791PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDE
    58517-160paroxetine hydrochlorideparoxetine hydrochloride
    60505-3673PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDE
    60505-3674PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDE
    60505-3675PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDE
    62175-470Paroxetine HydrochlorideParoxetine Hydrochloride
    62175-471Paroxetine HydrochlorideParoxetine Hydrochloride
    62175-472Paroxetine HydrochlorideParoxetine Hydrochloride
    63629-4615PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDE
    70518-2118Paroxetine HydrochlorideParoxetine Hydrochloride
    71335-1205Paroxetine HydrochlorideParoxetine Hydrochloride
    60505-1317PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDE
    60505-1318PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDE
    60505-1316PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDE
    0904-5676PAROXETINEparoxetine hydrochloride
    0904-5677PAROXETINEparoxetine hydrochloride
    0904-5678PAROXETINEparoxetine hydrochloride
    0904-5679PAROXETINEparoxetine hydrochloride
    10544-433PAROXETINEparoxetine hydrochloride
    10544-809PAROXETINEparoxetine hydrochloride
    12634-248PAROXETINEparoxetine hydrochloride
    16714-181ParoxetineParoxetine Hydrochloride
    16714-182ParoxetineParoxetine Hydrochloride
    16714-183ParoxetineParoxetine Hydrochloride
    16714-184ParoxetineParoxetine Hydrochloride
    21695-101ParoxetineParoxetine Hydrochloride
    21695-102ParoxetineParoxetine Hydrochloride
    21695-103ParoxetineParoxetine Hydrochloride
    21695-104ParoxetineParoxetine Hydrochloride
    43353-845ParoxetineParoxetine Hydrochloride
    21695-159PAXILparoxetine hydrochloride
    21695-160PAXILparoxetine hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.