NDC 54458-989

Paroxetine

Paroxetine Hydrochloride

Paroxetine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by International Laboratories, Llc. The primary component is Paroxetine Hydrochloride Hemihydrate.

Product ID54458-989_3f7396e1-a66e-4ba9-bb4e-b074d72721e4
NDC54458-989
Product TypeHuman Prescription Drug
Proprietary NameParoxetine
Generic NameParoxetine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2007-12-11
Marketing CategoryANDA / ANDA
Application NumberANDA077584
Labeler NameInternational Laboratories, LLC
Substance NamePAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active Ingredient Strength20 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 54458-989-10

30 TABLET in 1 BLISTER PACK (54458-989-10)
Marketing Start Date2007-12-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54458-989-10 [54458098910]

Paroxetine TABLET
Marketing CategoryANDA
Application NumberANDA077584
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-12-11
Marketing End Date2019-11-30

NDC 54458-989-04 [54458098904]

Paroxetine TABLET
Marketing CategoryANDA
Application NumberANDA077584
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-01
Marketing End Date2011-09-29

NDC 54458-989-16 [54458098916]

Paroxetine TABLET
Marketing CategoryANDA
Application NumberANDA077584
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-07-11

Drug Details

Active Ingredients

IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE20 mg/1

OpenFDA Data

SPL SET ID:49d3b871-f9fd-4d58-8405-8682c0c6e238
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1738495
  • 1738503
  • 1738483
    • UPC Code
  • 0354458989166
  • 0354458989104
  • 0354458990162
  • 0354458988107
  • 0354458988169
  • 0354458990100

    • Pharmacological Class

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

    Medicade Reported Pricing

    54458098916 PAROXETINE HCL 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    54458098910 PAROXETINE HCL 20 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.