NDC 68788-0797

Paroxetine

Paroxetine Hydrochloride

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 ID68788-0797_24949123-9c8c-4d9f-b736-ce6666181877
NDC68788-0797
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 NamePreferred Pharmaceuticals, Inc
Substance NamePAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active Ingredient Strength10 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68788-0797-1

100 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (68788-0797-1)
Marketing Start Date2007-04-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-0797-9 [68788079709]

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

NDC 68788-0797-6 [68788079706]

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

NDC 68788-0797-3 [68788079703]

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

NDC 68788-0797-8 [68788079708]

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

NDC 68788-0797-1 [68788079701]

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

Drug Details

Active Ingredients

IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE10 mg/1

OpenFDA Data

SPL SET ID:605c1d23-c97c-4ea4-92d0-fed351de9d2e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1738495
  • 1738483

    • Pharmacological Class

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