NDC 49999-632

PAROXETINE

Paroxetine Hydrochloride

PAROXETINE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Paroxetine Hydrochloride Hemihydrate.

Product ID49999-632_310d646b-aced-4527-895d-8aa619802ef3
NDC49999-632
Product TypeHuman Prescription Drug
Proprietary NamePAROXETINE
Generic NameParoxetine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-11-08
Marketing CategoryANDA /
Application NumberANDA077584
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NamePAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active Ingredient Strength20 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 49999-632-30

30 TABLET, FILM COATED in 1 BOTTLE (49999-632-30)
Marketing Start Date2011-11-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49999-632-30 [49999063230]

PAROXETINE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077584
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-11-08
Marketing End Date2018-10-11

NDC 49999-632-60 [49999063260]

PAROXETINE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077584
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-11-08
Marketing End Date2018-10-11

NDC 49999-632-00 [49999063200]

PAROXETINE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077584
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-11-08
Marketing End Date2014-06-01

Drug Details

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

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
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
70518-1210ParoxetineParoxetine
70518-0964PAROXETINEPAROXETINE
70518-1253ParoxetineParoxetine
70518-0739ParoxetineParoxetine
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