NDC 60505-0402

PAXIL

Paroxetine Hydrochloride

PAXIL is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Apotex Corp. The primary component is Paroxetine Hydrochloride Hemihydrate.

Product ID60505-0402_2063c19d-13c4-7185-b321-732164db8236
NDC60505-0402
Product TypeHuman Prescription Drug
Proprietary NamePAXIL
Generic NameParoxetine Hydrochloride
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2011-01-01
Marketing CategoryNDA / NDA
Application NumberNDA020710
Labeler NameApotex Corp
Substance NamePAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active Ingredient Strength10 mg/5mL
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 60505-0402-5

250 mL in 1 BOTTLE (60505-0402-5)
Marketing Start Date2011-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60505-0402-5 [60505040205]

PAXIL SUSPENSION
Marketing CategoryNDA
Application NumberNDA020710
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-01-01
Marketing End Date2021-09-30

Drug Details

Active Ingredients

IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE10 mg/5mL

OpenFDA Data

SPL SET ID:584ace29-6e40-432f-950f-ab7e98653d32
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312242
  • 1738495
  • 1738511
  • 1738503
  • 1738483
  • 211700
  • 211699
  • 207349
  • 213291
  • 207350
    • UPC Code
  • 0360505366637
  • 0360505366330
  • 0360505040254
  • 0360505366439
  • 0360505366538

    • Pharmacological Class

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

    Medicade Reported Pricing

    60505040205 PAXIL 10 MG/5 ML SUSPENSION

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "PAXIL" or generic name "Paroxetine Hydrochloride"

    NDCBrand NameGeneric Name
    21695-159PAXILparoxetine hydrochloride
    21695-160PAXILparoxetine hydrochloride
    60505-4519PAXILPAXIL
    60505-4517PAXILPAXIL
    60505-4520PAXILPAXIL
    60505-3665PAXILPAXIL
    60505-0402PAXILPAXIL
    60505-3664PAXILPAXIL
    60505-3666PAXILPAXIL
    60505-3663PAXILPAXIL
    60505-4518PAXILPAXIL
    70518-2500PAXILPAXIL
    70518-2636PAXILPAXIL
    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
    0378-2003Paroxetine Hydrochlorideparoxetine hydrochloride
    0378-2004Paroxetine Hydrochlorideparoxetine hydrochloride
    0378-2005Paroxetine Hydrochlorideparoxetine hydrochloride

    Trademark Results [PAXIL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PAXIL
    PAXIL
    75284309 2220043 Live/Registered
    GLAXOSMITHKLINE LLC
    1997-04-30
    PAXIL
    PAXIL
    75282874 2220037 Live/Registered
    GLAXOSMITHKLINE LLC
    1997-04-30
    PAXIL
    PAXIL
    75180864 not registered Dead/Abandoned
    SmithKline Beecham Corporation
    1996-10-15
    PAXIL
    PAXIL
    75180863 not registered Dead/Abandoned
    SmithKline Beecham Corporation
    1996-10-15
    PAXIL
    PAXIL
    75169719 2219909 Live/Registered
    GLAXOSMITHKLINE LLC
    1996-09-20
    PAXIL
    PAXIL
    75169698 2166898 Dead/Cancelled
    SmithKline Beecham Corporation
    1996-09-20
    PAXIL
    PAXIL
    75169697 2219908 Live/Registered
    GLAXOSMITHKLINE LLC
    1996-09-20
    PAXIL
    PAXIL
    75169675 2144154 Live/Registered
    GLAXOSMITHKLINE LLC
    1996-09-20
    PAXIL
    PAXIL
    74184442 1821952 Live/Registered
    GLAXOSMITHKLINE LLC
    1991-07-12
    PAXIL
    PAXIL
    73255881 1170889 Dead/Cancelled
    Boehringer Ingelheim G.m.b.H.
    1980-03-28
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