paroxetine

Generic: paroxetine hydrochloride hemihydrate

Labeler: rhodes pharmaceuticals l.p.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine hydrochloride hemihydrate
Labeler rhodes pharmaceuticals l.p.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

paroxetine hydrochloride 25 mg/1

Manufacturer
Rhodes Pharmaceuticals L.P.

Identifiers & Regulatory

Product NDC 42858-705
Product ID 42858-705_e1121b5e-880e-4da8-b4c9-ce8210448c76
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209293
Marketing Start 2018-09-14
Marketing End 2026-07-31

Pharmacologic Class

Classes
serotonin reuptake inhibitor [epc] serotonin uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42858705
Hyphenated Format 42858-705

Supplemental Identifiers

RxCUI
1738803 1738805 1738807
UNII
X2ELS050D8

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name paroxetine (source: ndc)
Generic Name paroxetine hydrochloride hemihydrate (source: ndc)
Application Number ANDA209293 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42858-705-03)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42858-705-50)
source: ndc

Packages (2)

42858-705-03 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42858-705-03) 42858-705-50 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42858-705-50)

Ingredients (1)

paroxetine hydrochloride (25 mg/1)

Linked Drug Pages (1)

PAROXETINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e1121b5e-880e-4da8-b4c9-ce8210448c76", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["1738803", "1738805", "1738807"], "spl_set_id": ["f562ab1a-adb9-4154-81cd-ceb480234331"], "manufacturer_name": ["Rhodes Pharmaceuticals L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42858-705-03)", "package_ndc": "42858-705-03", "marketing_end_date": "20260731", "marketing_start_date": "20180914"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42858-705-50)", "package_ndc": "42858-705-50", "marketing_end_date": "20260731", "marketing_start_date": "20180914"}], "brand_name": "PAROXETINE", "product_id": "42858-705_e1121b5e-880e-4da8-b4c9-ce8210448c76", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "42858-705", "generic_name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "labeler_name": "Rhodes Pharmaceuticals L.P.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PAROXETINE", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA209293", "marketing_category": "ANDA", "marketing_end_date": "20260731", "marketing_start_date": "20180914"}