paroxetine

Generic: paroxetine

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

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

paroxetine hydrochloride hemihydrate 25 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-646
Product ID 68180-646_1a9bc25c-db83-42a0-851a-30212ee10cc6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204134
Listing Expiration 2026-12-31
Marketing Start 2017-03-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180646
Hyphenated Format 68180-646

Supplemental Identifiers

RxCUI
1738803 1738805 1738807
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 ANDA204134 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-646-06)
source: ndc

Packages (1)

68180-646-06 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-646-06)

Ingredients (1)

paroxetine hydrochloride hemihydrate (25 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": "1a9bc25c-db83-42a0-851a-30212ee10cc6", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["1738803", "1738805", "1738807"], "spl_set_id": ["d315e0da-f829-408b-be5d-2bca2e06913c"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-646-06)", "package_ndc": "68180-646-06", "marketing_start_date": "20170306"}], "brand_name": "PAROXETINE", "product_id": "68180-646_1a9bc25c-db83-42a0-851a-30212ee10cc6", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "68180-646", "generic_name": "PAROXETINE", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PAROXETINE", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "strength": "25 mg/1"}], "application_number": "ANDA204134", "marketing_category": "ANDA", "marketing_start_date": "20170306", "listing_expiration_date": "20261231"}