paroxetine hydrochloride

Generic: paroxetine hydrochloride

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine hydrochloride
Generic Name paroxetine hydrochloride
Labeler lannett company, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

paroxetine hydrochloride 12.5 mg/1

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 62175-470
Product ID 62175-470_9474f942-d6d8-486b-8ea6-f8c561bb5014
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 62175470
Hyphenated Format 62175-470

Supplemental Identifiers

RxCUI
1738803 1738805 1738807
UPC
0362175470324
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 hydrochloride (source: ndc)
Generic Name paroxetine hydrochloride (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 (62175-470-32)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-470-41)
source: ndc

Packages (2)

62175-470-32 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-470-32) 62175-470-41 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-470-41)

Ingredients (1)

paroxetine hydrochloride (12.5 mg/1)

Linked Drug Pages (1)

Paroxetine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9474f942-d6d8-486b-8ea6-f8c561bb5014", "openfda": {"upc": ["0362175470324"], "unii": ["X2ELS050D8"], "rxcui": ["1738803", "1738805", "1738807"], "spl_set_id": ["f22886f5-230c-47e4-9dd8-ffb14c8d6ae4"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-470-32)", "package_ndc": "62175-470-32", "marketing_start_date": "20141031"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-470-41)", "package_ndc": "62175-470-41", "marketing_start_date": "20141031"}], "brand_name": "Paroxetine Hydrochloride", "product_id": "62175-470_9474f942-d6d8-486b-8ea6-f8c561bb5014", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "62175-470", "generic_name": "Paroxetine Hydrochloride", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine Hydrochloride", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE", "strength": "12.5 mg/1"}], "application_number": "ANDA204744", "marketing_category": "ANDA", "marketing_start_date": "20141031", "listing_expiration_date": "20261231"}