paroxetine

Generic: paroxetine

Labeler: aurolife pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine
Labeler aurolife pharma llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride hemihydrate 10 mg/1

Manufacturer
Aurolife Pharma LLC

Identifiers & Regulatory

Product NDC 13107-154
Product ID 13107-154_c399d3cd-13a5-4493-9a93-c4bf5e2532fc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078406
Listing Expiration 2026-12-31
Marketing Start 2009-12-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13107154
Hyphenated Format 13107-154

Supplemental Identifiers

RxCUI
1738483 1738495 1738503 1738511
UPC
0313107155307 0313107154300
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 ANDA078406 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (13107-154-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (13107-154-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (13107-154-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (13107-154-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (13107-154-99)
source: ndc

Packages (5)

13107-154-01 100 TABLET, FILM COATED in 1 BOTTLE (13107-154-01) 13107-154-05 500 TABLET, FILM COATED in 1 BOTTLE (13107-154-05) 13107-154-30 30 TABLET, FILM COATED in 1 BOTTLE (13107-154-30) 13107-154-90 90 TABLET, FILM COATED in 1 BOTTLE (13107-154-90) 13107-154-99 1000 TABLET, FILM COATED in 1 BOTTLE (13107-154-99)

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": "c399d3cd-13a5-4493-9a93-c4bf5e2532fc", "openfda": {"upc": ["0313107155307", "0313107154300"], "unii": ["X2ELS050D8"], "rxcui": ["1738483", "1738495", "1738503", "1738511"], "spl_set_id": ["e1ea4019-bb66-403c-a3d5-6ae056a59116"], "manufacturer_name": ["Aurolife Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (13107-154-01)", "package_ndc": "13107-154-01", "marketing_start_date": "20091203"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (13107-154-05)", "package_ndc": "13107-154-05", "marketing_start_date": "20091203"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (13107-154-30)", "package_ndc": "13107-154-30", "marketing_start_date": "20091203"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (13107-154-90)", "package_ndc": "13107-154-90", "marketing_start_date": "20091203"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (13107-154-99)", "package_ndc": "13107-154-99", "marketing_start_date": "20091203"}], "brand_name": "Paroxetine", "product_id": "13107-154_c399d3cd-13a5-4493-9a93-c4bf5e2532fc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "13107-154", "generic_name": "Paroxetine", "labeler_name": "Aurolife Pharma LLC", "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": "20091203", "listing_expiration_date": "20261231"}