paroxetine

Generic: paroxetine

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine
Labeler direct_rx
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride hemihydrate 10 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-492
Product ID 72189-492_2c4e39ee-1b27-61c5-e063-6394a90aeef5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077584
Listing Expiration 2026-12-31
Marketing Start 2023-06-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189492
Hyphenated Format 72189-492

Supplemental Identifiers

RxCUI
1738483
UNII
X2ELS050D8

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 ANDA077584 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (72189-492-30)
source: ndc

Packages (1)

72189-492-30 30 TABLET, FILM COATED in 1 BOTTLE (72189-492-30)

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": "2c4e39ee-1b27-61c5-e063-6394a90aeef5", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["1738483"], "spl_set_id": ["fea936a5-fdeb-e4fb-e053-6294a90a8995"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72189-492-30)", "package_ndc": "72189-492-30", "marketing_start_date": "20230621"}], "brand_name": "Paroxetine", "product_id": "72189-492_2c4e39ee-1b27-61c5-e063-6394a90aeef5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "72189-492", "generic_name": "Paroxetine", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "strength": "10 mg/1"}], "application_number": "ANDA077584", "marketing_category": "ANDA", "marketing_start_date": "20230621", "listing_expiration_date": "20261231"}