paroxetine hydrochloride
These highlights do not include all the information needed to use Paroxetine tablets, USP safely and effectively. See full prescribing information for Paroxetine tablets, USP. Paroxetine tablets, USP, for oral useInitial U.S. Approval: 1992
Approved
Approval ID
25182b68-8f7a-48e8-9788-6818b0984b29
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2022
Manufacturers
FDA
Oxford Pharmaceuticals, LLC
DUNS: 079638266
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 Code69584-673
Application NumberANDA076968
Product Classification
M
Marketing Category
C73584
G
Generic Name
paroxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2022
FDA Product Classification
INGREDIENTS (9)
Paroxetine HydrochlorideActive
Quantity: 30 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
Dibasic Calcium Phosphate DihydrateInactive
Code: O7TSZ97GEP
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
PolydextroseInactive
Code: VH2XOU12IE
Classification: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
TriacetinInactive
Code: XHX3C3X673
Classification: IACT
paroxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69584-671
Application NumberANDA076968
Product Classification
M
Marketing Category
C73584
G
Generic Name
paroxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2022
FDA Product Classification
INGREDIENTS (10)
Dibasic Calcium Phosphate DihydrateInactive
Code: O7TSZ97GEP
Classification: IACT
Paroxetine HydrochlorideActive
Quantity: 10 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
PolydextroseInactive
Code: VH2XOU12IE
Classification: IACT
TriacetinInactive
Code: XHX3C3X673
Classification: IACT
Fd&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
paroxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69584-672
Application NumberANDA076968
Product Classification
M
Marketing Category
C73584
G
Generic Name
paroxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2022
FDA Product Classification
INGREDIENTS (12)
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
PolydextroseInactive
Code: VH2XOU12IE
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
TriacetinInactive
Code: XHX3C3X673
Classification: IACT
D&C Yellow No. 10 Aluminum LakeInactive
Code: CQ3XH3DET6
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
Paroxetine HydrochlorideActive
Quantity: 20 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
Dibasic Calcium Phosphate DihydrateInactive
Code: O7TSZ97GEP
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
paroxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69584-674
Application NumberANDA076968
Product Classification
M
Marketing Category
C73584
G
Generic Name
paroxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2022
FDA Product Classification
INGREDIENTS (13)
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
Paroxetine HydrochlorideActive
Quantity: 40 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
Fd&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
Indigotindisulfonate SodiumInactive
Code: D3741U8K7L
Classification: IACT
Dibasic Calcium Phosphate DihydrateInactive
Code: O7TSZ97GEP
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
PolydextroseInactive
Code: VH2XOU12IE
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
TriacetinInactive
Code: XHX3C3X673
Classification: IACT
Fd&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT