paroxetine

Generic: paroxetine

Labeler: yiling pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine
Labeler yiling pharmaceutical, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride hemihydrate 10 mg/1

Manufacturer
Yiling Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 69117-0024
Product ID 69117-0024_472863af-ee04-24a6-e063-6394a90a9e20
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211248
Listing Expiration 2026-12-31
Marketing Start 2021-11-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 691170024
Hyphenated Format 69117-0024

Supplemental Identifiers

RxCUI
1738483 1738495 1738503 1738511
UPC
0369117002612 0369117002438 0369117002735 0369117002537 0369117002445 0369117002728 0369117002636 0369117002643 0369117002520 0369117002452 0369117002414 0369117002759 0369117002421 0369117002650 0369117002551 0369117002742 0369117002513 0369117002544 0369117002711
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 (source: ndc)
Application Number ANDA211248 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0024-1)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0024-2)
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0024-3)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0024-4)
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0024-5)
source: ndc

Packages (5)

69117-0024-1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0024-1) 69117-0024-2 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0024-2) 69117-0024-3 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0024-3) 69117-0024-4 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0024-4) 69117-0024-5 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0024-5)

Ingredients (1)

paroxetine hydrochloride hemihydrate (10 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": "472863af-ee04-24a6-e063-6394a90a9e20", "openfda": {"upc": ["0369117002612", "0369117002438", "0369117002735", "0369117002537", "0369117002445", "0369117002728", "0369117002636", "0369117002643", "0369117002520", "0369117002452", "0369117002414", "0369117002759", "0369117002421", "0369117002650", "0369117002551", "0369117002742", "0369117002513", "0369117002544", "0369117002711"], "unii": ["X2ELS050D8"], "rxcui": ["1738483", "1738495", "1738503", "1738511"], "spl_set_id": ["4abd94c5-5ad5-4a43-9c51-a93ea1c1f3bc"], "manufacturer_name": ["Yiling Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0024-1)", "package_ndc": "69117-0024-1", "marketing_start_date": "20211102"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0024-2)", "package_ndc": "69117-0024-2", "marketing_start_date": "20211102"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0024-3)", "package_ndc": "69117-0024-3", "marketing_start_date": "20211102"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0024-4)", "package_ndc": "69117-0024-4", "marketing_start_date": "20211102"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0024-5)", "package_ndc": "69117-0024-5", "marketing_start_date": "20211102"}], "brand_name": "Paroxetine", "product_id": "69117-0024_472863af-ee04-24a6-e063-6394a90a9e20", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "69117-0024", "generic_name": "Paroxetine", "labeler_name": "Yiling Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "strength": "10 mg/1"}], "application_number": "ANDA211248", "marketing_category": "ANDA", "marketing_start_date": "20211102", "listing_expiration_date": "20261231"}