NDC 60505-1318

PAROXETINE HYDROCHLORIDE

Paroxetine Hydrochloride

PAROXETINE HYDROCHLORIDE 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 ID60505-1318_622ce70e-22cd-ae3c-c309-5ff4c4dd75e3
NDC60505-1318
Product TypeHuman Prescription Drug
Proprietary NamePAROXETINE HYDROCHLORIDE
Generic NameParoxetine Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-08-09
Marketing CategoryNDA / NDA
Application NumberNDA020936
Labeler NameApotex Corp
Substance NamePAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active Ingredient Strength38 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 60505-1318-3

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-1318-3)
Marketing Start Date2019-08-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60505-1318-3 [60505131803]

PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020936
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-09

Drug Details

Active Ingredients

IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE37.5 mg/1

OpenFDA Data

SPL SET ID:087ff0d3-1761-47ea-a8c1-7c4cb679af97
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1738803
  • 1738805
  • 1738807
    • UPC Code
  • 0360505367535
  • 0360505367337
  • 0360505367436

    • Pharmacological Class

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

    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
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