NDC 68788-9718

Paroxetine

Paroxetine

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

Product ID68788-9718_b3d2349a-9bb1-4bbe-8ad1-3da3ff513021
NDC68788-9718
Product TypeHuman Prescription Drug
Proprietary NameParoxetine
Generic NameParoxetine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-12-20
Marketing CategoryANDA / ANDA
Application NumberANDA078406
Labeler NamePreferred Pharmaceuticals, Inc.
Substance NamePAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active Ingredient Strength10 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 68788-9718-1

100 TABLET, FILM COATED in 1 BOTTLE (68788-9718-1)
Marketing Start Date2012-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-9718-6 [68788971806]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078406
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-12-20
Inactivation Date2020-01-31

NDC 68788-9718-8 [68788971808]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078406
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-12-20
Inactivation Date2020-01-31

NDC 68788-9718-1 [68788971801]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078406
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-12-20
Inactivation Date2020-01-31

NDC 68788-9718-3 [68788971803]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078406
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-12-20
Inactivation Date2020-01-31

NDC 68788-9718-2 [68788971802]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078406
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-12-20
Inactivation Date2020-01-31

NDC 68788-9718-9 [68788971809]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078406
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-12-20
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE10 mg/1

OpenFDA Data

SPL SET ID:da0a8f1e-44ad-4487-9bdc-ddbce9a23321
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1738495
  • 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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