FDA.reportPublic FDA data

Paroxetine Hydrochloride Hemihydrate

Manufacturer
AX Pharmaceutical Corp
Effective date
2019-03-27
Label type
BULK INGREDIENT
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:28:47

Label at a glance#

ProductParoxetine Hydrochloride Hemihydrate
Active ingredientPAROXETINE HYDROCHLORIDE HEMIHYDRATE
Label structure1 sections

Label contents#

Full prescribing information#

Paroxetine Hydrochloride Hemihydrate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62157-80062157-800-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
PAROXETINE HYDROCHLORIDE HEMIHYDRATEX2ELS050D8ACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEREMEDYREPACK INC.88b4c469-19b3-44b9-a378-c7c3f4f436db2026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEREMEDYREPACK INC.4cb9dc05-adb8-4c88-ad40-af8c0df1cafd2026-07-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEREMEDYREPACK INC.22174520-4b78-4841-96f7-530ba12d2cf12026-07-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEREMEDYREPACK INC.90c129a8-afce-4b8b-85d7-f89e6da2aef72026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEREMEDYREPACK INC.009d8b89-eab9-43ba-b077-86bfa993a7452026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEREMEDYREPACK INC.28ddc9e0-05c5-482f-9371-60bbee451b332026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATENuCare Pharmaceuticals, Inc.54efbbc1-4f5f-262d-e063-6394a90aadbc2026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEPD-Rx Pharmaceuticals, Inc.619e10bb-6e5d-4ec3-a85a-6270965f53892026-06-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEPD-Rx Pharmaceuticals, Inc.ff7c7e20-c9ee-4693-beaa-7ac532d5c4b72026-06-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEMylan Pharmaceuticals Inc.89dd7e24-85fc-4152-89ea-47ec2b48a1ed2026-02-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATENuCare Pharmaceuticals, Inc.49dd0858-685f-f46b-e063-6294a90a7f392026-02-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEPreferred Pharmaceuticals Inc.2b2e6cd0-d779-4b7b-b3aa-85b796874ac32026-01-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATENuCare Pharmaceuticals, Inc.34909bfb-b4ad-25c4-e063-6294a90a02962025-08-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEPD-Rx Pharmaceuticals, Inc.d551f3d0-9503-45bd-b701-dfed4c8a5e1e2025-02-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEPD-Rx Pharmaceuticals, Inc.65c81817-34d3-4c57-a4bf-fb10be98386d2025-02-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEPreferred Pharmaceuticals Inc.91c5a321-e174-4d86-9a84-e5e278d45aff2025-02-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATESolco Healthcare US, LLC6cfde064-ddcb-49df-a53c-953c40eb14702024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEBryant Ranch Prepackac6ea24f-a9f3-4413-8c3a-9e2e4ca93c0f2024-06-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEProficient Rx LPce168c41-a860-45f5-bae8-7b3d9b48d86a2024-06-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEProficient Rx LP903e4ef1-487d-4b65-9038-b05ceaf74d192024-05-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.