paroxetine

Generic: paroxetine

Labeler: modavar pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine
Labeler modavar pharmaceuticals llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

paroxetine hydrochloride hemihydrate 37.5 mg/1

Manufacturer
Modavar Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72241-031
Product ID 72241-031_1d6895c1-d0ec-48f1-ad90-5c16d582a049
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212645
Listing Expiration 2026-12-31
Marketing Start 2021-10-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72241031
Hyphenated Format 72241-031

Supplemental Identifiers

RxCUI
1738803 1738805 1738807
UPC
0372241031229 0372241031106 0372241029103 0372241030109 0372241029226 0372241030222
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 ANDA212645 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 37.5 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72241-031-10)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72241-031-22)
source: ndc

Packages (2)

72241-031-10 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72241-031-10) 72241-031-22 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72241-031-22)

Ingredients (1)

paroxetine hydrochloride hemihydrate (37.5 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": "1d6895c1-d0ec-48f1-ad90-5c16d582a049", "openfda": {"upc": ["0372241031229", "0372241031106", "0372241029103", "0372241030109", "0372241029226", "0372241030222"], "unii": ["X2ELS050D8"], "rxcui": ["1738803", "1738805", "1738807"], "spl_set_id": ["555cfa31-3865-450f-b16b-2f4004af7a67"], "manufacturer_name": ["Modavar Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72241-031-10)", "package_ndc": "72241-031-10", "marketing_start_date": "20211020"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72241-031-22)", "package_ndc": "72241-031-22", "marketing_start_date": "20211020"}], "brand_name": "Paroxetine", "product_id": "72241-031_1d6895c1-d0ec-48f1-ad90-5c16d582a049", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "72241-031", "generic_name": "Paroxetine", "labeler_name": "Modavar Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "strength": "37.5 mg/1"}], "application_number": "ANDA212645", "marketing_category": "ANDA", "marketing_start_date": "20211020", "listing_expiration_date": "20261231"}