NDC 65862-157

Paroxetine

Paroxetine Hydrochloride

Paroxetine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Paroxetine Hydrochloride Hemihydrate.

Product ID65862-157_6f8ba9ce-9927-4127-ac80-c2256ca8c5da
NDC65862-157
Product TypeHuman Prescription Drug
Proprietary NameParoxetine
Generic NameParoxetine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-07-25
Marketing CategoryANDA / DRUG FOR FURTHER PROCESSING
Application NumberANDA078406
Labeler NameAurobindo Pharma Limited
Substance NamePAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active Ingredient Strength40 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 65862-157-01

100 TABLET, FILM COATED in 1 BOTTLE (65862-157-01)
Marketing Start Date2007-07-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-157-90 [65862015790]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078406
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-07-25

NDC 65862-157-05 [65862015705]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078406
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-07-25

NDC 65862-157-99 [65862015799]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078406
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-07-25

NDC 65862-157-01 [65862015701]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078406
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-07-25

NDC 65862-157-39 [65862015739]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078406
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-12-21
Marketing End Date2012-09-24

NDC 65862-157-30 [65862015730]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078406
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-07-25

Drug Details

Active Ingredients

IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE40 mg/1

Medicade Reported Pricing

65862015799 PAROXETINE HCL 40 MG TABLET

Pricing Unit: EA | Drug Type:

65862015730 PAROXETINE HCL 40 MG TABLET

Pricing Unit: EA | Drug Type:

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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