NDC 53808-0748

paroxetine

Paroxetine Hydrochloride

paroxetine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by State Of Florida Doh Central Pharmacy. The primary component is Paroxetine Hydrochloride.

Product ID53808-0748_051db7fe-e4d6-4022-a00a-069d14dbaf64
NDC53808-0748
Product TypeHuman Prescription Drug
Proprietary Nameparoxetine
Generic NameParoxetine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-07-01
Marketing CategoryANDA / ANDA
Application NumberANDA075356
Labeler NameState of Florida DOH Central Pharmacy
Substance NamePAROXETINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53808-0748-1

30 TABLET in 1 BLISTER PACK (53808-0748-1)
Marketing Start Date2009-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53808-0748-1 [53808074801]

paroxetine TABLET
Marketing CategoryANDA
Application NumberANDA075356
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-01
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
PAROXETINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:c9b57101-2455-463d-b8d7-b2316cecd67a
Manufacturer
RxNorm Concept Unique ID - RxCUI
  • 1738495
  • 1738511
  • 1738503
  • 1738483
  • UPC Code
  • 0360505008346
  • 0360505009749
  • 0360505010141
  • 0360505008445
  • 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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