NDC 59746-458

Paroxetine

Paroxetine Hydrochloride Hemihydrate

Paroxetine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Jubilant Cadista Pharmaceuticals Inc.. The primary component is Paroxetine Hydrochloride Hemihydrate.

Product ID59746-458_304e02c2-48d3-4f9e-a7de-8d9be564580b
NDC59746-458
Product TypeHuman Prescription Drug
Proprietary NameParoxetine
Generic NameParoxetine Hydrochloride Hemihydrate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-11-20
Marketing CategoryANDA / ANDA
Application NumberANDA205528
Labeler NameJubilant Cadista Pharmaceuticals Inc.
Substance NamePAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active Ingredient Strength20 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 59746-458-01

100 TABLET, FILM COATED in 1 BOTTLE (59746-458-01)
Marketing Start Date2015-11-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59746-458-90 [59746045890]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205528
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-11-27
Marketing End Date2019-11-30

NDC 59746-458-07 [59746045807]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205528
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-11-20
Marketing End Date2018-01-24

NDC 59746-458-10 [59746045810]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205528
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-11-27
Marketing End Date2019-11-30

NDC 59746-458-01 [59746045801]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205528
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-11-27
Marketing End Date2019-11-30

NDC 59746-458-30 [59746045830]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205528
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-11-27
Marketing End Date2019-11-30

Drug Details

Active Ingredients

IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE20 mg/1

OpenFDA Data

SPL SET ID:899aee24-bd00-ee0a-669d-f4fbe96ef269
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1738495
  • 1738511
  • 1738503
  • 1738483
    • UPC Code
  • 0359746459307
  • 0359746458300
  • 0359746460303
  • 0359746457303

    • Pharmacological Class

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

    Medicade Reported Pricing

    59746045890 PAROXETINE HCL 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    59746045830 PAROXETINE HCL 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    59746045810 PAROXETINE HCL 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    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.