NDC 70954-319

Paroxetine

Paroxetine

Paroxetine is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Novitium Pharma Llc. The primary component is Paroxetine Hydrochloride Hemihydrate.

Product ID70954-319_134e76f0-45cf-47eb-b6e1-cdb3bb522a0a
NDC70954-319
Product TypeHuman Prescription Drug
Proprietary NameParoxetine
Generic NameParoxetine
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2021-09-03
Marketing CategoryANDA /
Application NumberANDA215003
Labeler NameNovitium Pharma LLC
Substance NamePAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active Ingredient Strength10 mg/5mL
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 70954-319-10

250 mL in 1 BOTTLE (70954-319-10)
Marketing Start Date2021-09-03
NDC Exclude FlagN
Sample Package?N

Drug Details

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
10544-433PAROXETINEparoxetine hydrochloride
10544-809PAROXETINEparoxetine hydrochloride
12634-248PAROXETINEparoxetine hydrochloride
13107-154ParoxetineParoxetine
13107-155ParoxetineParoxetine
13107-156ParoxetineParoxetine
13107-157ParoxetineParoxetine
21695-101ParoxetineParoxetine Hydrochloride
21695-102ParoxetineParoxetine Hydrochloride
21695-103ParoxetineParoxetine 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

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