NDC 0615-5576

Paroxetine

Paroxetine

Paroxetine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Paroxetine Hydrochloride Hemihydrate.

Product ID0615-5576_641d859d-3a27-4b7d-9c9f-e2b0cbb3a449
NDC0615-5576
Product TypeHuman Prescription Drug
Proprietary NameParoxetine
Generic NameParoxetine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-03-07
Marketing CategoryANDA / ANDA
Application NumberANDA077584
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
Substance NamePAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active Ingredient Strength10 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0615-5576-39

30 TABLET, FILM COATED in 1 BLISTER PACK (0615-5576-39)
Marketing Start Date2007-03-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-5576-05 [00615557605]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077584
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-03-07
Inactivation Date2020-01-31

NDC 0615-5576-39 [00615557639]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077584
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-03-07
Inactivation Date2020-01-31

NDC 0615-5576-31 [00615557631]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077584
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-03-07
Marketing End Date2013-12-30

Drug Details

Active Ingredients

IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE10 mg/1

OpenFDA Data

SPL SET ID:7b9e9d36-9b7d-4d47-8d8a-d37da85e7b24
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1738495
  • 1738511
  • 1738503
  • 1738483

    • Pharmacological Class

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

    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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