NDC 68180-647

PAROXETINE

Paroxetine

PAROXETINE is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is Paroxetine Hydrochloride Hemihydrate.

Product ID68180-647_1dcb4824-4c74-483e-8508-a1e1531e63c0
NDC68180-647
Product TypeHuman Prescription Drug
Proprietary NamePAROXETINE
Generic NameParoxetine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-03-06
Marketing CategoryANDA / ANDA
Application NumberANDA204134
Labeler NameLupin Pharmaceuticals, Inc.
Substance NamePAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active Ingredient Strength13 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68180-647-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-647-01)
Marketing Start Date2017-03-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68180-647-03 [68180064703]

PAROXETINE TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204134
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-06

NDC 68180-647-06 [68180064706]

PAROXETINE TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204134
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-06

NDC 68180-647-01 [68180064701]

PAROXETINE TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204134
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-06

NDC 68180-647-02 [68180064702]

PAROXETINE TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204134
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-06

Drug Details

Active Ingredients

IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE12.5 mg/1

OpenFDA Data

SPL SET ID:d315e0da-f829-408b-be5d-2bca2e06913c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1738803
  • 1738805
  • 1738807
  • Pharmacological Class

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

    Medicade Reported Pricing

    68180064706 PAROXETINE ER 12.5 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "PAROXETINE" or generic name "Paroxetine"

    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
    0904-5676PAROXETINEparoxetine hydrochloride
    0904-5677PAROXETINEparoxetine hydrochloride
    0904-5678PAROXETINEparoxetine hydrochloride
    0904-5679PAROXETINEparoxetine hydrochloride
    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

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