paroxetine

Generic: paroxetine hydrochloride

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine hydrochloride
Labeler cardinal health 107, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride anhydrous 20 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-7999
Product ID 55154-7999_224dfb62-6c9f-435c-b760-434430075a5c
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 551547999
Hyphenated Format 55154-7999

Supplemental Identifiers

RxCUI
1738495
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
  • 1 BLISTER PACK in 1 BAG (55154-7999-0) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

55154-7999-0 1 BLISTER PACK in 1 BAG (55154-7999-0) / 10 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": "224dfb62-6c9f-435c-b760-434430075a5c", "openfda": {"unii": ["3I3T11UD2S"], "rxcui": ["1738495"], "spl_set_id": ["333dfd07-61f0-4b86-b4b5-b04adf64e49f"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 BAG (55154-7999-0)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "55154-7999-0", "marketing_start_date": "20030908"}], "brand_name": "PAROXETINE", "product_id": "55154-7999_224dfb62-6c9f-435c-b760-434430075a5c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "55154-7999", "generic_name": "paroxetine hydrochloride", "labeler_name": "Cardinal Health 107, LLC", "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"}