NDC 0378-2003

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 Mylan Pharmaceuticals Inc.. The primary component is Paroxetine Hydrochloride Hemihydrate.

Product ID0378-2003_30d34031-72b1-4a11-b9b5-7483af26e94c
NDC0378-2003
Product TypeHuman Prescription Drug
Proprietary NameParoxetine Hydrochloride
Generic NameParoxetine Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2008-05-14
Marketing CategoryANDA / ANDA
Application NumberANDA077873
Labeler NameMylan Pharmaceuticals Inc.
Substance NamePAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active Ingredient Strength13 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-2003-93

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0378-2003-93)
Marketing Start Date2008-05-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-2003-93 [00378200393]

Paroxetine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077873
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-05-14

NDC 0378-2003-05 [00378200305]

Paroxetine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077873
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-05-14
Marketing End Date2019-11-30

NDC 0378-2003-01 [00378200301]

Paroxetine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077873
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-05-14
Marketing End Date2014-10-23

Drug Details

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
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.