paroxetine

Generic: paroxetine

Labeler: cadila pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine
Labeler cadila pharmaceuticals limited
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

paroxetine hydrochloride hemihydrate 12.5 mg/1

Manufacturer
Cadila Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 71209-094
Product ID 71209-094_03756846-6e37-4c43-9a84-58e06801336a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212645
Listing Expiration 2026-12-31
Marketing Start 2020-02-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71209094
Hyphenated Format 71209-094

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 ANDA212645 (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 (71209-094-01)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71209-094-10)
source: ndc

Packages (2)

71209-094-01 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71209-094-01) 71209-094-10 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71209-094-10)

Ingredients (1)

paroxetine hydrochloride hemihydrate (12.5 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": "03756846-6e37-4c43-9a84-58e06801336a", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["1738803", "1738805", "1738807"], "spl_set_id": ["5e43cdbd-2419-434b-96b9-920f02558d1c"], "manufacturer_name": ["Cadila Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71209-094-01)", "package_ndc": "71209-094-01", "marketing_start_date": "20200214"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71209-094-10)", "package_ndc": "71209-094-10", "marketing_start_date": "20200214"}], "brand_name": "Paroxetine", "product_id": "71209-094_03756846-6e37-4c43-9a84-58e06801336a", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "71209-094", "generic_name": "Paroxetine", "labeler_name": "Cadila Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "strength": "12.5 mg/1"}], "application_number": "ANDA212645", "marketing_category": "ANDA", "marketing_start_date": "20200214", "listing_expiration_date": "20261231"}