PAROXETINE
These highlights do not include all the information needed to use Paroxetine Extended-Release Tablets, USP safely and effectively. See full prescribing information for Paroxetine Extended-Release Tablets, USP. Paroxetine Extended-Release Tablets, USP for oral use Initial U.S. Approval: 1992
Approved
Approval ID
f562ab1a-adb9-4154-81cd-ceb480234331
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2024
Manufacturers
FDA
Rhodes Pharmaceuticals L.P.
DUNS: 831928986
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42858-703
Application NumberANDA209293
Product Classification
M
Marketing Category
C73584
G
Generic Name
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2023
FDA Product Classification
INGREDIENTS (14)
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PAROXETINE HYDROCHLORIDEActive
Quantity: 12.5 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
Glyceryl MonostearateInactive
Code: 230OU9XXE4
Classification: IACT
Hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Triethyl CitrateInactive
Code: 8Z96QXD6UM
Classification: IACT
Silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42858-707
Application NumberANDA209293
Product Classification
M
Marketing Category
C73584
G
Generic Name
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2023
FDA Product Classification
INGREDIENTS (16)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
PAROXETINE HYDROCHLORIDEActive
Quantity: 37.5 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
Glyceryl MonostearateInactive
Code: 230OU9XXE4
Classification: IACT
Hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
Silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Triethyl CitrateInactive
Code: 8Z96QXD6UM
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42858-705
Application NumberANDA209293
Product Classification
M
Marketing Category
C73584
G
Generic Name
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2023
FDA Product Classification
INGREDIENTS (16)
PAROXETINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
Hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
Glyceryl MonostearateInactive
Code: 230OU9XXE4
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Triethyl CitrateInactive
Code: 8Z96QXD6UM
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT