Paroxetine
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE tablets, USP film coated for oral use Initial U.S. Approval: 1992
Approved
Approval ID
34909bfb-b4ad-25c4-e063-6294a90a0296
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 7, 2025
Manufacturers
FDA
NuCare Pharmaceuticals, Inc.
DUNS: 010632300
Products 1
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 Code68071-3843
Application NumberANDA203854
Product Classification
M
Marketing Category
C73584
G
Generic Name
paroxetine hydrochloride hemihydrate
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification
INGREDIENTS (9)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM PALMITOSTEARATEInactive
Code: R4OXA9G5BV
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PAROXETINE HYDROCHLORIDE HEMIHYDRATEActive
Quantity: 10 mg in 1 1
Code: X2ELS050D8
Classification: ACTIM
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT