United States · FDA National Drug Code directory
Paroxetine
A source-listed medicine record.
Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.
Medicine identity
- Source reference
- 43353-544_37d67ac2-1470-43aa-a06d-b24981539fd4
- Product NDC
- 43353-544
- Form
- TABLET, FILM COATED
- Composition / generic term
- paroxetine hydrochloride hemihydrate
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20080324
- Source listing expiry
- 20261231
Source-listed ingredients
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE — 40 mg/1
These values do not establish equivalence or a dose recommendation.
Packages
- 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-544-15) · 43353-544-15
- 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-544-30) · 43353-544-30
- 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-544-45) · 43353-544-45
- 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-544-60) · 43353-544-60
Source and coverage
Open FDA National Drug Code directory →
Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.
Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.
Browse United States records →