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
Routes
ORAL
Active Ingredients

paroxetine hydrochloride hemihydrate 30 mg/1

Manufacturer
Chartwell RX, LLC.

Identifiers & Regulatory

Product NDC 62135-543
Product ID 62135-543_4687b126-663e-b64a-e063-6294a90affa1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211248
Listing Expiration 2026-12-31
Marketing Start 2021-11-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135543
Hyphenated Format 62135-543

Supplemental Identifiers

RxCUI
1738483 1738495 1738503 1738511
UPC
0362135544904 0362135542900 0362135541903 0362135543907
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 ANDA211248 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (62135-543-90)
source: ndc

Packages (1)

62135-543-90 90 TABLET, FILM COATED in 1 BOTTLE (62135-543-90)

Ingredients (1)

paroxetine hydrochloride hemihydrate (30 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": "4687b126-663e-b64a-e063-6294a90affa1", "openfda": {"upc": ["0362135544904", "0362135542900", "0362135541903", "0362135543907"], "unii": ["X2ELS050D8"], "rxcui": ["1738483", "1738495", "1738503", "1738511"], "spl_set_id": ["69699d40-4a64-4337-8664-e4e093437fbf"], "manufacturer_name": ["Chartwell RX, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (62135-543-90)", "package_ndc": "62135-543-90", "marketing_start_date": "20230411"}], "brand_name": "PAROXETINE", "product_id": "62135-543_4687b126-663e-b64a-e063-6294a90affa1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "62135-543", "generic_name": "PAROXETINE", "labeler_name": "Chartwell RX, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PAROXETINE", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "strength": "30 mg/1"}], "application_number": "ANDA211248", "marketing_category": "ANDA", "marketing_start_date": "20211102", "listing_expiration_date": "20261231"}