NDC 71335-1205

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.

Product ID71335-1205_ad690c46-52c0-4bfe-83b9-ceb032343dfe
NDC71335-1205
Product TypeHuman Prescription Drug
Proprietary NameParoxetine Hydrochloride
Generic NameParoxetine Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2014-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA204744
Labeler NameBryant Ranch Prepack
Substance NamePAROXETINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 71335-1205-1

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1205-1)
Marketing Start Date2021-12-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-1205-4 [71335120504]

Paroxetine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204744
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-31

NDC 71335-1205-3 [71335120503]

Paroxetine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204744
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-31

NDC 71335-1205-2 [71335120502]

Paroxetine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204744
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-31

NDC 71335-1205-5 [71335120505]

Paroxetine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204744
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-31

NDC 71335-1205-1 [71335120501]

Paroxetine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204744
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-31

Drug Details

Active Ingredients

IngredientStrength
PAROXETINE HYDROCHLORIDE ANHYDROUS25 mg/1

OpenFDA Data

SPL SET ID:ad690c46-52c0-4bfe-83b9-ceb032343dfe
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1738805

    • 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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