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Paroxetine Hydrochloride
Paroxetine Hydrochloride - 0378-2005-05 - (paroxetine hydrochloride)
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: | 0378-2005-05 |
| Package Description: | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0378-2005-05) |
NDC Information of Paroxetine Hydrochloride
| NDC Code | 0378-2005-05 |
| Proprietary Name | Paroxetine Hydrochloride |
| Package Description | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0378-2005-05) |
| 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] |
