NDC 70518-2598

Paroxetine

Paroxetine Hydrochloride Hemihydrate

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

Product ID70518-2598_9f8874db-7d30-36ff-e053-2a95a90a32d1
NDC70518-2598
Product TypeHuman Prescription Drug
Proprietary NameParoxetine
Generic NameParoxetine Hydrochloride Hemihydrate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-02-25
Marketing CategoryANDA / ANDA
Application NumberANDA203854
Labeler NameREMEDYREPACK INC.
Substance NamePAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active Ingredient Strength30 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 70518-2598-0

30 POUCH in 1 BOX (70518-2598-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-2598-1)
Marketing Start Date2020-02-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-2598-1 [70518259801]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203854
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-25

NDC 70518-2598-0 [70518259800]

Paroxetine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203854
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-25

Drug Details

Active Ingredients

IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE30 mg/1

Pharmacological Class

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

NDC Crossover Matching brand name "Paroxetine" or generic name "Paroxetine Hydrochloride Hemihydrate"

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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