Home NDC 60505-3665 PAXIL
Product NDC 60505-3665
11-digit product format 605053665
Labeler code 60505
Product ID 60505-3665_a407612e-c30d-6993-a3d4-4e10ed05a4ea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name paroxetine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Apotex Corp
Application NDA020031
Marketing category NDA
Marketing start 2011-01-01
Marketing end 2020-10-31
Substance PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength 30 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020031-001 PAXIL PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB RLD 1992-12-29 N020031-002 PAXIL PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RLD 1992-12-29 N020031-003 PAXIL PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB RLD 1992-12-29 N020031-004 PAXIL PAROXETINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 1992-12-29 N020031-005 PAXIL PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB RLD, RS 1992-12-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N020031-001 PAXIL EQ 10MG BASE TABLET / ORAL AB RLD 1992-12-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N020031-002 PAXIL EQ 20MG BASE TABLET / ORAL AB RLD 1992-12-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N020031-003 PAXIL EQ 30MG BASE TABLET / ORAL AB RLD 1992-12-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N020031-004 PAXIL EQ 50MG BASE TABLET / ORAL 1992-12-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N020031-005 PAXIL EQ 40MG BASE TABLET / ORAL AB RLD, RS 1992-12-29 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PAXIL PAROXETINE HYDROCHLORIDE Apotex Corp ef3b5cbe-f9e1-c1ac-79da-cfe14e3a7e7e 2024-10-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020031 application number: NDA020031