NDC 60505-4378

PAXIL CR

Paroxetine Hydrochloride

PAXIL CR is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Apotex Corp. The primary component is Paroxetine Hydrochloride Hemihydrate.

Product ID60505-4378_10f7d0ca-3710-c45c-eb05-8de85aa51b95
NDC60505-4378
Product TypeHuman Prescription Drug
Proprietary NamePAXIL CR
Generic NameParoxetine Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2011-01-01
Marketing CategoryNDA / NDA
Application NumberNDA020936
Labeler NameApotex Corp
Substance NamePAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active Ingredient Strength25 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 60505-4378-3

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-4378-3)
Marketing Start Date2011-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60505-4378-3 [60505437803]

PAXIL CR TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020936
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-01

Drug Details

Active Ingredients

IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE25 mg/1

OpenFDA Data

SPL SET ID:483bd97f-c4d0-4e23-aaa8-6334f4471e0c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1738808
  • 1738803
  • 1738804
  • 1738805
  • 1738806
  • 1738807
    • UPC Code
  • 0360505366934
  • 0360505366835

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    71335-0572PAXIL CRPAXIL CR
    60505-3669PAXIL CRPAXIL CR
    60505-3670PAXIL CRPAXIL CR
    60505-3668PAXIL CRPAXIL CR
    60505-4378PAXIL CRPAXIL CR
    60505-4377PAXIL CRPAXIL CR
    60505-4379PAXIL CRPAXIL CR
    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
    21695-159PAXILparoxetine hydrochloride
    21695-160PAXILparoxetine 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.