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Paroxetine Hydrochloride - 0378-2005-01 - (paroxetine hydrochloride)

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Drug Information of Paroxetine Hydrochloride

Product NDC: 0378-2005
Proprietary Name: Paroxetine Hydrochloride
Non Proprietary Name: paroxetine hydrochloride
Active Ingredient(s): 37.5    mg/1 & nbsp;   paroxetine hydrochloride
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED, EXTENDED RELEASE
Coding System: National Drug Codes(NDC)

Labeler Information of Paroxetine Hydrochloride

Product NDC: 0378-2005
Labeler Name: Mylan Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA091427
Marketing Category: ANDA
Start Marketing Date: 20130204

Package Information of Paroxetine Hydrochloride

Package NDC: 0378-2005-01
Package Description: 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0378-2005-01)

NDC Information of Paroxetine Hydrochloride

NDC Code 0378-2005-01
Proprietary Name Paroxetine Hydrochloride
Package Description 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0378-2005-01)
Product NDC 0378-2005
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name paroxetine hydrochloride
Dosage Form Name TABLET, FILM COATED, EXTENDED RELEASE
Route Name ORAL
Start Marketing Date 20130204
Marketing Category Name ANDA
Labeler Name Mylan Pharmaceuticals Inc.
Substance Name PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Strength Number 37.5
Strength Unit mg/1
Pharmaceutical Classes Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]

Complete Information of Paroxetine Hydrochloride


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