NDC 43547-350

Paroxetine

Paroxetine Hydrochloride Hemihydrate

Paroxetine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Solco Healthcare Us, Llc. The primary component is Paroxetine Hydrochloride Hemihydrate.

Product ID43547-350_4df42bf8-2500-4af5-bde5-1df2033188c6
NDC43547-350
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 NameSolco Healthcare US, LLC
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 43547-350-03

30 TABLET, FILM COATED in 1 BOTTLE (43547-350-03)
Marketing Start Date2014-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43547-350-50 [43547035050]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203854
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-11-01

NDC 43547-350-11 [43547035011]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203854
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-11-01

NDC 43547-350-03 [43547035003]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203854
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-11-01

NDC 43547-350-09 [43547035009]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203854
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-11-01

Drug Details

Active Ingredients

IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE40 mg/1

OpenFDA Data

SPL SET ID:6cfde064-ddcb-49df-a53c-953c40eb1470
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1738495
  • 1738511
  • 1738503
  • 1738483
    • UPC Code
  • 0343547350031
  • 0343547349035
  • 0343547348038
  • 0343547347031

    • Pharmacological Class

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

    Medicade Reported Pricing

    43547035050 PAROXETINE HCL 40 MG TABLET

    Pricing Unit: EA | Drug Type:

    43547035011 PAROXETINE HCL 40 MG TABLET

    Pricing Unit: EA | Drug Type:

    43547035009 PAROXETINE HCL 40 MG TABLET

    Pricing Unit: EA | Drug Type:

    43547035003 PAROXETINE HCL 40 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
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