paroxetine

Generic: paroxetine hydrochloride hemihydrate

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine hydrochloride hemihydrate
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride 20 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-7985
Product ID 0615-7985_34c4cb21-d274-4d85-90f4-df09a9beffd8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203854
Listing Expiration 2026-12-31
Marketing Start 2014-11-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06157985
Hyphenated Format 0615-7985

Supplemental Identifiers

RxCUI
1738495 1738503 1738511
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 hydrochloride hemihydrate (source: ndc)
Application Number ANDA203854 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7985-05)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7985-39)
source: ndc

Packages (2)

0615-7985-05 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7985-05) 0615-7985-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7985-39)

Ingredients (1)

paroxetine hydrochloride (20 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": "34c4cb21-d274-4d85-90f4-df09a9beffd8", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["1738495", "1738503", "1738511"], "spl_set_id": ["c3b2ce88-6f09-4f7b-ac73-93dca84aa3b8"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7985-05)", "package_ndc": "0615-7985-05", "marketing_start_date": "20160516"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7985-39)", "package_ndc": "0615-7985-39", "marketing_start_date": "20160516"}], "brand_name": "Paroxetine", "product_id": "0615-7985_34c4cb21-d274-4d85-90f4-df09a9beffd8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "0615-7985", "generic_name": "paroxetine hydrochloride hemihydrate", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA203854", "marketing_category": "ANDA", "marketing_start_date": "20141101", "listing_expiration_date": "20261231"}