paroxetine

Generic: paroxetine hydrochloride hemihydrate

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine hydrochloride hemihydrate
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride 10 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-7001
Product ID 0378-7001_b237829d-df98-4a31-b048-91740cf88a63
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078902
Listing Expiration 2026-12-31
Marketing Start 2008-03-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03787001
Hyphenated Format 0378-7001

Supplemental Identifiers

RxCUI
1738483 1738495 1738503 1738511
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 hydrochloride hemihydrate (source: ndc)
Application Number ANDA078902 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7001-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7001-93)
source: ndc

Packages (2)

0378-7001-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7001-10) 0378-7001-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7001-93)

Ingredients (1)

paroxetine hydrochloride (10 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": "b237829d-df98-4a31-b048-91740cf88a63", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["1738483", "1738495", "1738503", "1738511"], "spl_set_id": ["89dd7e24-85fc-4152-89ea-47ec2b48a1ed"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7001-10)", "package_ndc": "0378-7001-10", "marketing_start_date": "20080324"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7001-93)", "package_ndc": "0378-7001-93", "marketing_start_date": "20080324"}], "brand_name": "Paroxetine", "product_id": "0378-7001_b237829d-df98-4a31-b048-91740cf88a63", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "0378-7001", "generic_name": "paroxetine hydrochloride hemihydrate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078902", "marketing_category": "ANDA", "marketing_start_date": "20080324", "listing_expiration_date": "20261231"}