Paroxetine
Paroxetine Tablets, USP
Approved
Approval ID
49d3b871-f9fd-4d58-8405-8682c0c6e238
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2019
Manufacturers
FDA
International Laboratories, LLC
DUNS: 023569924
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Paroxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54458-989
Application NumberANDA077584
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paroxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 23, 2019
FDA Product Classification
INGREDIENTS (10)
PAROXETINE HYDROCHLORIDE HEMIHYDRATEActive
Quantity: 20 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Paroxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54458-988
Application NumberANDA077584
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paroxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 23, 2019
FDA Product Classification
INGREDIENTS (10)
PAROXETINE HYDROCHLORIDE HEMIHYDRATEActive
Quantity: 30 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
Paroxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54458-990
Application NumberANDA077584
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paroxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 23, 2019
FDA Product Classification
INGREDIENTS (10)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
PAROXETINE HYDROCHLORIDE HEMIHYDRATEActive
Quantity: 10 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT