paroxetine

Generic: paroxetine

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

paroxetine hydrochloride 12.5 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-425
Product ID 62135-425_efb6b453-333a-211d-e053-2995a90ae2d9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204744
Listing Expiration 2026-12-31
Marketing Start 2014-10-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135425
Hyphenated Format 62135-425

Supplemental Identifiers

RxCUI
1738803 1738805 1738807
UPC
0362135426309 0362135425302 0362135427306
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 ANDA204744 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62135-425-30)
source: ndc

Packages (1)

62135-425-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62135-425-30)

Ingredients (1)

paroxetine hydrochloride (12.5 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": "efb6b453-333a-211d-e053-2995a90ae2d9", "openfda": {"upc": ["0362135426309", "0362135425302", "0362135427306"], "unii": ["X2ELS050D8"], "rxcui": ["1738803", "1738805", "1738807"], "spl_set_id": ["52c3c5c4-6434-4f95-b5f0-9ecfdc0a7e0a"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62135-425-30)", "package_ndc": "62135-425-30", "marketing_start_date": "20221205"}], "brand_name": "Paroxetine", "product_id": "62135-425_efb6b453-333a-211d-e053-2995a90ae2d9", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "62135-425", "generic_name": "Paroxetine", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE", "strength": "12.5 mg/1"}], "application_number": "ANDA204744", "marketing_category": "ANDA", "marketing_start_date": "20141031", "listing_expiration_date": "20261231"}