paroxetine

Generic: paroxetine

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

Drug Facts

Product Profile

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

paroxetine hydrochloride hemihydrate 25 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-767
Product ID 46708-767_59cb7de6-483d-4007-b6ef-f10a70b872e9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217280
Listing Expiration 2026-12-31
Marketing Start 2025-09-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708767
Hyphenated Format 46708-767

Supplemental Identifiers

RxCUI
1738805 1738807
UPC
0346708768300
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 ANDA217280 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-767-30)
  • 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-767-91)
source: ndc

Packages (2)

46708-767-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-767-30) 46708-767-91 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-767-91)

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": "59cb7de6-483d-4007-b6ef-f10a70b872e9", "openfda": {"upc": ["0346708768300"], "unii": ["X2ELS050D8"], "rxcui": ["1738805", "1738807"], "spl_set_id": ["59cb7de6-483d-4007-b6ef-f10a70b872e9"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-767-30)", "package_ndc": "46708-767-30", "marketing_start_date": "20250930"}, {"sample": false, "description": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-767-91)", "package_ndc": "46708-767-91", "marketing_start_date": "20250930"}], "brand_name": "Paroxetine", "product_id": "46708-767_59cb7de6-483d-4007-b6ef-f10a70b872e9", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "46708-767", "generic_name": "Paroxetine", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "strength": "25 mg/1"}], "application_number": "ANDA217280", "marketing_category": "ANDA", "marketing_start_date": "20250930", "listing_expiration_date": "20261231"}