NDC 68084-044

Paroxetine

Paroxetine Hydrochloride

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

Product ID68084-044_84afbd4c-5ee8-d7ae-e053-2991aa0a7133
NDC68084-044
Product TypeHuman Prescription Drug
Proprietary NameParoxetine
Generic NameParoxetine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2008-01-16
Marketing CategoryANDA / ANDA
Application NumberANDA077584
Labeler NameAmerican Health Packaging
Substance NamePAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active Ingredient Strength10 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68084-044-01

100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-044-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-044-11)
Marketing Start Date2008-01-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68084-044-01 [68084004401]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077584
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-16

NDC 68084-044-11 [68084004411]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077584
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-16

Drug Details

Active Ingredients

IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE10 mg/1

OpenFDA Data

SPL SET ID:b5a8f864-a53d-48d9-aca6-6b64017fb168
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1738495
  • 1738511
  • 1738503
  • 1738483

    • Pharmacological Class

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

    Medicade Reported Pricing

    68084044911 TACROLIMUS 0.5 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    68084044901 TACROLIMUS 0.5 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    68084044821 ANASTROZOLE 1 MG TABLET

    Pricing Unit: EA | Drug Type:

    68084044811 ANASTROZOLE 1 MG TABLET

    Pricing Unit: EA | Drug Type:

    68084044711 HYDRALAZINE 10 MG TABLET

    Pricing Unit: EA | Drug Type:

    68084044701 HYDRALAZINE 10 MG TABLET

    Pricing Unit: EA | Drug Type:

    68084044611 NITROFURANTOIN MONO-MCR 100 MG

    Pricing Unit: EA | Drug Type:

    68084044601 NITROFURANTOIN MONO-MCR 100 MG

    Pricing Unit: EA | Drug Type:

    68084044411 CARBAMAZEPINE 200 MG TABLET

    Pricing Unit: EA | Drug Type:

    68084044401 CARBAMAZEPINE 200 MG TABLET

    Pricing Unit: EA | Drug Type:

    68084044011 PRAMIPEXOLE 0.25 MG TABLET

    Pricing Unit: EA | Drug Type:

    68084044001 PRAMIPEXOLE 0.25 MG TABLET

    Pricing Unit: EA | Drug Type:

    68084004411 PAROXETINE HCL 10 MG TABLET

    Pricing Unit: EA | Drug Type:

    68084004401 PAROXETINE HCL 10 MG TABLET

    Pricing Unit: EA | Drug Type:

    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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.