NDC 55700-379

Paroxetine

Paroxetine Hydrochloride Hemihydrate

Paroxetine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Qua. The primary component is Paroxetine Hydr.

Product ID55700-379_3c811a07-7c56-4483-b010-6c6865d9fa43
NDC55700-379
Product TypeHuman Prescription Drug
Proprietary NameParoxetine
Generic NameParoxetine Hydrochloride Hemihydrate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA203854
Labeler NameLake Erie Medical DBA Qua
Substance NamePAROXETINE HYDR
Active Ingredient Strength20 mg/1
Pharm ClassesSerotonin Reupt
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55700-379-30

30 TABLET, FILM COATED in 1 BOTTLE (55700-379-30)
Marketing Start Date2016-02-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55700-379-60 [55700037960]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203854
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-02-19

NDC 55700-379-90 [55700037990]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203854
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-02-19
Marketing End Date2019-10-11

NDC 55700-379-30 [55700037930]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203854
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-02-19

Drug Details

Pharmacological Class

  • Serotonin Reuptake Inhibitor [EPC]
  • Serotonin Uptake Inhibitors [MoA]

NDC Crossover Matching brand name "Paroxetine" or generic name "Paroxetine Hydrochloride Hemihydrate"

NDCBrand NameGeneric Name
0378-7001Paroxetineparoxetine hydrochloride hemihydrate
0378-7002Paroxetineparoxetine hydrochloride hemihydrate
0378-7003Paroxetineparoxetine hydrochloride hemihydrate
0378-7004Paroxetineparoxetine hydrochloride hemihydrate
0574-0279Paroxetineparoxetine
0615-5576ParoxetineParoxetine
0615-5577ParoxetineParoxetine
0615-5578ParoxetineParoxetine
0615-5579ParoxetineParoxetine
0615-7985Paroxetineparoxetine hydrochloride hemihydrate
0615-8173ParoxetineParoxetine
0615-8174ParoxetineParoxetine
0615-8359ParoxetineParoxetine
0904-5676PAROXETINEparoxetine hydrochloride
0904-5677PAROXETINEparoxetine hydrochloride
0904-5678PAROXETINEparoxetine hydrochloride
0904-5679PAROXETINEparoxetine hydrochloride
68071-1594ParoxetineParoxetine
68071-1746ParoxetineParoxetine
68071-1740ParoxetineParoxetine
68071-3278ParoxetineParoxetine
68071-4323PAROXETINEPAROXETINE
68071-4315ParoxetineParoxetine
68071-4283PAROXETINEPAROXETINE
68071-4316ParoxetineParoxetine
68084-044ParoxetineParoxetine
68084-045ParoxetineParoxetine
68084-047ParoxetineParoxetine
68084-046ParoxetineParoxetine
68180-647PAROXETINEPAROXETINE
68180-645PAROXETINEPAROXETINE
68180-646PAROXETINEPAROXETINE
68382-097ParoxetineParoxetine
68382-001ParoxetineParoxetine
68382-099ParoxetineParoxetine
68382-098ParoxetineParoxetine
68788-0797ParoxetineParoxetine
68788-7410ParoxetineParoxetine
68788-9074ParoxetineParoxetine
68788-9118ParoxetineParoxetine
68788-6977ParoxetineParoxetine
68788-6870ParoxetineParoxetine
68788-9694PAROXETINEPAROXETINE
68788-6985ParoxetineParoxetine
68788-9719ParoxetineParoxetine
68788-9718ParoxetineParoxetine
70518-0003ParoxetineParoxetine
70518-0320ParoxetineParoxetine
70518-0550ParoxetineParoxetine
70518-0958ParoxetineParoxetine

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.