NDC 57664-425

Paroxetine

Paroxetine

Paroxetine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Paroxetine Hydrochloride Hemihydrate.

Product ID57664-425_38e34831-580e-4773-a1a8-7358fee2424e
NDC57664-425
Product TypeHuman Prescription Drug
Proprietary NameParoxetine
Generic NameParoxetine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2007-06-29
Marketing CategoryANDA / ANDA
Application NumberANDA078194
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NamePAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active Ingredient Strength40 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 57664-425-08

100 TABLET in 1 BOTTLE (57664-425-08)
Marketing Start Date2007-06-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57664-425-08 [57664042508]

Paroxetine TABLET
Marketing CategoryANDA
Application NumberANDA078194
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-06-29
Marketing End Date2016-08-31

NDC 57664-425-99 [57664042599]

Paroxetine TABLET
Marketing CategoryANDA
Application NumberANDA078194
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-06-29
Marketing End Date2016-08-31

NDC 57664-425-83 [57664042583]

Paroxetine TABLET
Marketing CategoryANDA
Application NumberANDA078194
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-06-29
Marketing End Date2016-08-31

NDC 57664-425-18 [57664042518]

Paroxetine TABLET
Marketing CategoryANDA
Application NumberANDA078194
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-06-29
Marketing End Date2016-08-31

NDC 57664-425-13 [57664042513]

Paroxetine TABLET
Marketing CategoryANDA
Application NumberANDA078194
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-06-29
Marketing End Date2016-08-31

Drug Details

Active Ingredients

IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE40 mg/1

OpenFDA Data

SPL SET ID:6c47a65b-2665-4391-ad69-25c4f5a8b010
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1738495
  • 1738511
  • 1738503
  • 1738483

    • Pharmacological Class

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

    Medicade Reported Pricing

    57664042599 PAROXETINE HCL 40 MG TABLET

    Pricing Unit: EA | Drug Type:

    57664042583 PAROXETINE HCL 40 MG TABLET

    Pricing Unit: EA | Drug Type:

    57664042513 PAROXETINE HCL 40 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    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
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