NDC 65841-099

Paroxetine

Paroxetine Hydrochloride

Paroxetine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Lifesciences Limited. The primary component is Paroxetine Hydrochloride Anhydrous.

Product ID65841-099_50512e7e-5a95-42a1-acf9-9db1328739b6
NDC65841-099
Product TypeHuman Prescription Drug
Proprietary NameParoxetine
Generic NameParoxetine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-04-13
Marketing CategoryANDA / ANDA
Application NumberANDA077584
Labeler NameZydus Lifesciences Limited
Substance NamePAROXETINE HYDROCHLORIDE ANHYDROUS
Active Ingredient Strength30 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 65841-099-01

100 TABLET, FILM COATED in 1 BOTTLE (65841-099-01)
Marketing Start Date2007-04-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65841-099-05 [65841009905]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077584
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-04-13

NDC 65841-099-06 [65841009906]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077584
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-04-13

NDC 65841-099-01 [65841009901]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077584
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-04-13

NDC 65841-099-10 [65841009910]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077584
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-04-13

NDC 65841-099-16 [65841009916]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077584
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-04-13

Drug Details

Active Ingredients

IngredientStrength
PAROXETINE HYDROCHLORIDE ANHYDROUS30 mg/1

OpenFDA Data

SPL SET ID:6d5fcdb2-4d84-4b20-87e3-58a43e567500
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 Hydrochloride"

    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
    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
    70518-1210ParoxetineParoxetine
    70518-0964PAROXETINEPAROXETINE
    70518-1253ParoxetineParoxetine
    70518-0739ParoxetineParoxetine
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