paroxetine

Generic: paroxetine hydrochloride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine hydrochloride
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride hemihydrate 10 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-154
Product ID 65862-154_19f7a08f-58bd-45b8-a750-4432ae161455
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078406
Listing Expiration 2026-12-31
Marketing Start 2007-07-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862154
Hyphenated Format 65862-154

Supplemental Identifiers

RxCUI
1738483 1738495 1738503 1738511
UPC
0365862154019
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 (source: ndc)
Application Number ANDA078406 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65862-154-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-154-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-154-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65862-154-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-154-99)
source: ndc

Packages (5)

65862-154-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-154-01) 65862-154-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-154-05) 65862-154-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-154-30) 65862-154-90 90 TABLET, FILM COATED in 1 BOTTLE (65862-154-90) 65862-154-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-154-99)

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": "19f7a08f-58bd-45b8-a750-4432ae161455", "openfda": {"upc": ["0365862154019"], "unii": ["X2ELS050D8"], "rxcui": ["1738483", "1738495", "1738503", "1738511"], "spl_set_id": ["326e8ab0-6886-4749-9544-885b37070051"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65862-154-01)", "package_ndc": "65862-154-01", "marketing_start_date": "20070725"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-154-05)", "package_ndc": "65862-154-05", "marketing_start_date": "20070725"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-154-30)", "package_ndc": "65862-154-30", "marketing_start_date": "20070725"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65862-154-90)", "package_ndc": "65862-154-90", "marketing_start_date": "20070725"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-154-99)", "package_ndc": "65862-154-99", "marketing_start_date": "20070725"}], "brand_name": "Paroxetine", "product_id": "65862-154_19f7a08f-58bd-45b8-a750-4432ae161455", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "65862-154", "generic_name": "Paroxetine Hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "strength": "10 mg/1"}], "application_number": "ANDA078406", "marketing_category": "ANDA", "marketing_start_date": "20070725", "listing_expiration_date": "20261231"}