NDC 70518-2500

PAXIL

Paroxetine Hydrochloride

PAXIL is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Paroxetine Hydrochloride Hemihydrate.

Product ID70518-2500_9a08106b-620c-67ae-e053-2995a90a788c
NDC70518-2500
Product TypeHuman Prescription Drug
Proprietary NamePAXIL
Generic NameParoxetine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-12-18
Marketing CategoryNDA / NDA
Application NumberNDA020031
Labeler NameREMEDYREPACK INC.
Substance NamePAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active Ingredient Strength20 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-2500-0

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2500-0)
Marketing Start Date2019-12-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-2500-0 [70518250000]

PAXIL TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020031
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-18

Drug Details

Active Ingredients

IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE20 mg/1

OpenFDA Data

SPL SET ID:587e9f6d-0b76-47f6-b89d-cdbff2212046
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1738495
  • 207349

    • Pharmacological Class

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

    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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