paroxetine

Generic: paroxetine hydrochloride hemihydrate

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine hydrochloride hemihydrate
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride anhydrous 30 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5987
Product ID 50090-5987_3e8cfd15-4821-46d2-ae90-827bb859f71a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203854
Listing Expiration 2026-12-31
Marketing Start 2014-11-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500905987
Hyphenated Format 50090-5987

Supplemental Identifiers

RxCUI
1738503
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 hemihydrate (source: ndc)
Application Number ANDA203854 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-5987-0)
source: ndc

Packages (1)

50090-5987-0 90 TABLET, FILM COATED in 1 BOTTLE (50090-5987-0)

Ingredients (1)

paroxetine hydrochloride anhydrous (30 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": "3e8cfd15-4821-46d2-ae90-827bb859f71a", "openfda": {"unii": ["3I3T11UD2S"], "rxcui": ["1738503"], "spl_set_id": ["525884d7-e2ee-4d57-a6c9-bd129e9fb9d0"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-5987-0)", "package_ndc": "50090-5987-0", "marketing_start_date": "20220602"}], "brand_name": "Paroxetine", "product_id": "50090-5987_3e8cfd15-4821-46d2-ae90-827bb859f71a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "50090-5987", "generic_name": "paroxetine hydrochloride hemihydrate", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE ANHYDROUS", "strength": "30 mg/1"}], "application_number": "ANDA203854", "marketing_category": "ANDA", "marketing_start_date": "20141101", "listing_expiration_date": "20261231"}