NDC 70518-2118

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 ID70518-2118_89f95279-b5b4-5f39-e053-2995a90a7139
NDC70518-2118
Product TypeHuman Prescription Drug
Proprietary NameParoxetine Hydrochloride
Generic NameParoxetine Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-05-28
Marketing CategoryANDA / ANDA
Application NumberANDA204744
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 70518-2118-0

90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2118-0)
Marketing Start Date2019-05-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-2118-0 [70518211800]

Paroxetine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204744
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-28

Drug Details

Active Ingredients

IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE25 mg/1

OpenFDA Data

SPL SET ID:e14c6c14-1cf5-43c3-8f07-cf50b98d12e0
Manufacturer
UNII

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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