paroxetine

Generic: paroxetine hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine hydrochloride
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride anhydrous 20 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-5677
Product ID 0904-5677_9a171d3f-aa1b-4120-82ee-af67f33f167f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075356
Listing Expiration 2026-12-31
Marketing Start 2003-09-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09045677
Hyphenated Format 0904-5677

Supplemental Identifiers

RxCUI
1738483 1738495 1738503 1738511
UNII
3I3T11UD2S

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 (source: ndc)
Application Number ANDA075356 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-5677-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-5677-61 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-5677-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

paroxetine hydrochloride anhydrous (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": "9a171d3f-aa1b-4120-82ee-af67f33f167f", "openfda": {"unii": ["3I3T11UD2S"], "rxcui": ["1738483", "1738495", "1738503", "1738511"], "spl_set_id": ["84b1b1f0-d375-4fda-99af-9487f8ef50c7"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-5677-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-5677-61", "marketing_start_date": "20030908"}], "brand_name": "PAROXETINE", "product_id": "0904-5677_9a171d3f-aa1b-4120-82ee-af67f33f167f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "0904-5677", "generic_name": "paroxetine hydrochloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PAROXETINE", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE ANHYDROUS", "strength": "20 mg/1"}], "application_number": "ANDA075356", "marketing_category": "ANDA", "marketing_start_date": "20030908", "listing_expiration_date": "20261231"}