NDC 66116-434

Paroxetine

Paroxetine Hydrochloride

Paroxetine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Medvantx, Inc.. The primary component is Paroxetine Hydrochloride Anhydrous.

Product ID66116-434_b1894876-1824-4f87-95ed-d2a805683e15
NDC66116-434
Product TypeHuman Prescription Drug
Proprietary NameParoxetine
Generic NameParoxetine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2005-10-03
Marketing CategoryANDA / ANDA
Application NumberANDA076618
Labeler NameMedVantx, Inc.
Substance NamePAROXETINE HYDROCHLORIDE ANHYDROUS
Active Ingredient Strength20 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 66116-434-30

30 TABLET, FILM COATED in 1 BOTTLE (66116-434-30)
Marketing Start Date2005-10-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66116-434-30 [66116043430]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076618
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-10-03
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
PAROXETINE HYDROCHLORIDE ANHYDROUS20 mg/1

OpenFDA Data

SPL SET ID:b1894876-1824-4f87-95ed-d2a805683e15
Manufacturer
UNII

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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