Home NDC 60505-4518 PAXIL
Product NDC 60505-4518
11-digit product format 605054518
Labeler code 60505
Product ID 60505-4518_62b4ffe1-48e2-6dd5-d7ca-28e8efe36686
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 2019-03-11
Substance PAROXETINE HYDROCHLORIDE
Active strength 20 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 ndc (product): 60505-4518
Additional Listing Data#
Finished product Yes
Brand name base PAXIL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PAROXETINE HYDROCHLORIDE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X2ELS050D8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 207349 Internal RxNorm lookup 207350 Internal RxNorm lookup 211699 Internal RxNorm lookup 211700 Internal RxNorm lookup 1738483 Internal RxNorm lookup 1738495 Internal RxNorm lookup 1738503 Internal RxNorm lookup 1738511 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-4518-3 PAXIL 30 in 1 BOTTLE TABLET, FILM COATED 30 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-4518 PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP] 10 Current NDC, Legacy NDC, 1 package rows 20240912_ef3b5cbe-f9e1-c1ac-79da-cfe14e3a7e7e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60505-4518-3 60505451803 30 TABLET, FILM COATED in 1 BOTTLE (60505-4518-3) 2019-03-11 0000-00-00 No No Current