NDC 63629-4615

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 Bryant Ranch Prepack. The primary component is Paroxetine Hydrochloride Hemihydrate.

Product ID63629-4615_4c7ed1cf-75c6-461d-8bda-17955dadb43c
NDC63629-4615
Product TypeHuman Prescription Drug
Proprietary NamePAROXETINE HYDROCHLORIDE
Generic NameParoxetine Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2010-09-13
Marketing CategoryNDA / NDA
Application NumberNDA020936
Labeler NameBryant Ranch Prepack
Substance NamePAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active Ingredient Strength13 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 63629-4615-3

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4615-3)
Marketing Start Date2010-09-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-4615-1 [63629461501]

PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020936
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-13
Inactivation Date2020-01-31

NDC 63629-4615-3 [63629461503]

PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020936
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-13
Inactivation Date2020-01-31

NDC 63629-4615-4 [63629461504]

PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020936
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-13
Inactivation Date2020-01-31

NDC 63629-4615-5 [63629461505]

PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020936
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-13
Inactivation Date2020-01-31

NDC 63629-4615-2 [63629461502]

PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020936
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-13
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE12.5 mg/1

OpenFDA Data

SPL SET ID:13173c0f-5338-4be9-9f86-29da2dddac23
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1738803

    • Pharmacological Class

    • 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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