paroxetine

Generic: paroxetine

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride hemihydrate 10 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-0544
Product ID 71335-0544_2586816e-d449-4c27-a592-44ad6a2802da
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077584
Listing Expiration 2026-12-31
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 713350544
Hyphenated Format 71335-0544

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 (71335-0544-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71335-0544-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71335-0544-3)
  • 120 TABLET, FILM COATED in 1 BOTTLE (71335-0544-4)
  • 15 TABLET, FILM COATED in 1 BOTTLE (71335-0544-5)
  • 20 TABLET, FILM COATED in 1 BOTTLE (71335-0544-6)
  • 180 TABLET, FILM COATED in 1 BOTTLE (71335-0544-7)
source: ndc

Packages (7)

71335-0544-1 30 TABLET, FILM COATED in 1 BOTTLE (71335-0544-1) 71335-0544-2 60 TABLET, FILM COATED in 1 BOTTLE (71335-0544-2) 71335-0544-3 90 TABLET, FILM COATED in 1 BOTTLE (71335-0544-3) 71335-0544-4 120 TABLET, FILM COATED in 1 BOTTLE (71335-0544-4) 71335-0544-5 15 TABLET, FILM COATED in 1 BOTTLE (71335-0544-5) 71335-0544-6 20 TABLET, FILM COATED in 1 BOTTLE (71335-0544-6) 71335-0544-7 180 TABLET, FILM COATED in 1 BOTTLE (71335-0544-7)

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": "2586816e-d449-4c27-a592-44ad6a2802da", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["1738483"], "spl_set_id": ["7a702760-9b72-4595-bf47-01aff786c74d"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71335-0544-1)", "package_ndc": "71335-0544-1", "marketing_start_date": "20220209"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71335-0544-2)", "package_ndc": "71335-0544-2", "marketing_start_date": "20220209"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71335-0544-3)", "package_ndc": "71335-0544-3", "marketing_start_date": "20220209"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (71335-0544-4)", "package_ndc": "71335-0544-4", "marketing_start_date": "20220209"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71335-0544-5)", "package_ndc": "71335-0544-5", "marketing_start_date": "20220209"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (71335-0544-6)", "package_ndc": "71335-0544-6", "marketing_start_date": "20220209"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (71335-0544-7)", "package_ndc": "71335-0544-7", "marketing_start_date": "20220209"}], "brand_name": "Paroxetine", "product_id": "71335-0544_2586816e-d449-4c27-a592-44ad6a2802da", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "71335-0544", "generic_name": "Paroxetine", "labeler_name": "Bryant Ranch Prepack", "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": "20070413", "listing_expiration_date": "20261231"}