Paroxetine
PAROXETINE TABLETS USP
Approved
Approval ID
32fd11aa-2996-496d-ac3b-76a6afe22e3c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 11, 2010
Manufacturers
FDA
Contract Pharmacy Services-PA
DUNS: 945429777
Products 4
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 Code67046-531
Application NumberANDA077584
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paroxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2010
FDA Product Classification
INGREDIENTS (10)
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSE 2910 (6 CPS)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PAROXETINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 3I3T11UD2S
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
Paroxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-532
Application NumberANDA077584
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paroxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2010
FDA Product Classification
INGREDIENTS (10)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
PAROXETINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 3I3T11UD2S
Classification: ACTIB
HYPROMELLOSE 2910 (6 CPS)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
PEG-150 DISTEARATEInactive
Code: 6F36Q0I0AC
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
Paroxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-530
Application NumberANDA077584
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paroxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2010
FDA Product Classification
INGREDIENTS (10)
PAROXETINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 3I3T11UD2S
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSE 2910 (6 CPS)Inactive
Code: 0WZ8WG20P6
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
Paroxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-533
Application NumberANDA077584
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paroxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2010
FDA Product Classification
INGREDIENTS (10)
PAROXETINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: 3I3T11UD2S
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYPROMELLOSE 2910 (6 CPS)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PEG-150 DISTEARATEInactive
Code: 6F36Q0I0AC
Classification: IACT