paroxetine

Generic: paroxetine

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride 10 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-1297
Product ID 50090-1297_539e7ed9-6526-4b0f-be3c-eb212d39c653
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077584
Listing Expiration 2027-12-31
Marketing Start 2007-04-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500901297
Hyphenated Format 50090-1297

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
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-1297-0)
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-1297-1)
source: ndc

Packages (2)

50090-1297-0 90 TABLET, FILM COATED in 1 BOTTLE (50090-1297-0) 50090-1297-1 30 TABLET, FILM COATED in 1 BOTTLE (50090-1297-1)

Ingredients (1)

paroxetine hydrochloride (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": "539e7ed9-6526-4b0f-be3c-eb212d39c653", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["1738483"], "spl_set_id": ["31e4bb7c-59ab-4cbf-ba08-317c1417b28f"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-1297-0)", "package_ndc": "50090-1297-0", "marketing_start_date": "20141128"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-1297-1)", "package_ndc": "50090-1297-1", "marketing_start_date": "20141128"}], "brand_name": "Paroxetine", "product_id": "50090-1297_539e7ed9-6526-4b0f-be3c-eb212d39c653", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "50090-1297", "generic_name": "Paroxetine", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA077584", "marketing_category": "ANDA", "marketing_start_date": "20070413", "listing_expiration_date": "20271231"}