NDC 70518-1791

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 Remedyrepack Inc.. The primary component is Paroxetine Hydrochloride Hemihydrate.

Product ID70518-1791_7f386808-0bec-3019-e053-2991aa0a1abc
NDC70518-1791
Product TypeHuman Prescription Drug
Proprietary NamePAROXETINE HYDROCHLORIDE
Generic NameParoxetine Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-01-11
Marketing CategoryNDA / NDA
Application NumberNDA020936
Labeler NameREMEDYREPACK INC.
Substance NamePAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active Ingredient Strength25 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-1791-0

1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOX, UNIT-DOSE (70518-1791-0)
Marketing Start Date2019-01-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1791-1 [70518179101]

PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020936
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-11

NDC 70518-1791-0 [70518179100]

PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020936
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-11

Drug Details

Active Ingredients

IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE25 mg/1

OpenFDA Data

SPL SET ID:e2a47c25-9330-47f7-a4f4-4868d58440cc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1738805

    • 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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