Home NDC 60505-3666 PAXIL
Product NDC 60505-3666
11-digit product format 605053666
Labeler code 60505
Product ID 60505-3666_2063c19d-13c4-7185-b321-732164db8236
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 2021-05-31
Substance PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength 40 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 60505-3666-3 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 60505-3666-3 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 60505-3666-3 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 60505-3666-3 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 60505-3666-3 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 60505-3666-3 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 60505-3666-3 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 60505-3666-3 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 60505-3666-3 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 60505-3666-3 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 60505-3666-3 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 60505-3666-3 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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.
Product history page 1 of 6 · 210 observed 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 2026-08-18 06:07:40 2026-07 N020031-001 PAXIL EQ 10MG BASE TABLET / ORAL AB RLD 1992-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020031-002 PAXIL EQ 20MG BASE TABLET / ORAL AB RLD 1992-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020031-003 PAXIL EQ 30MG BASE TABLET / ORAL AB RLD 1992-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020031-004 PAXIL EQ 50MG BASE TABLET / ORAL 1992-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020031-005 PAXIL EQ 40MG BASE TABLET / ORAL AB RLD, RS 1992-12-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020031-001 PAXIL EQ 10MG BASE TABLET / ORAL AB RLD 1992-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020031-002 PAXIL EQ 20MG BASE TABLET / ORAL AB RLD 1992-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020031-003 PAXIL EQ 30MG BASE TABLET / ORAL AB RLD 1992-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020031-004 PAXIL EQ 50MG BASE TABLET / ORAL 1992-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020031-005 PAXIL EQ 40MG BASE TABLET / ORAL AB RLD, RS 1992-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020031-001 PAXIL EQ 10MG BASE TABLET / ORAL AB RLD 1992-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020031-002 PAXIL EQ 20MG BASE TABLET / ORAL AB RLD 1992-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020031-003 PAXIL EQ 30MG BASE TABLET / ORAL AB RLD 1992-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020031-004 PAXIL EQ 50MG BASE TABLET / ORAL 1992-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020031-005 PAXIL EQ 40MG BASE TABLET / ORAL AB RLD, RS 1992-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020031-001 PAXIL EQ 10MG BASE TABLET / ORAL AB RLD 1992-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020031-002 PAXIL EQ 20MG BASE TABLET / ORAL AB RLD 1992-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020031-003 PAXIL EQ 30MG BASE TABLET / ORAL AB RLD 1992-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020031-004 PAXIL EQ 50MG BASE TABLET / ORAL 1992-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020031-005 PAXIL EQ 40MG BASE TABLET / ORAL AB RLD, RS 1992-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020031-001 PAXIL EQ 10MG BASE TABLET / ORAL AB RLD 1992-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020031-002 PAXIL EQ 20MG BASE TABLET / ORAL AB RLD 1992-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020031-003 PAXIL EQ 30MG BASE TABLET / ORAL AB RLD 1992-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020031-004 PAXIL EQ 50MG BASE TABLET / ORAL 1992-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020031-005 PAXIL EQ 40MG BASE TABLET / ORAL AB RLD, RS 1992-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020031-001 PAXIL EQ 10MG BASE TABLET / ORAL AB RLD 1992-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020031-002 PAXIL EQ 20MG BASE TABLET / ORAL AB RLD 1992-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020031-003 PAXIL EQ 30MG BASE TABLET / ORAL AB RLD 1992-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020031-004 PAXIL EQ 50MG BASE TABLET / ORAL 1992-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020031-005 PAXIL EQ 40MG BASE TABLET / ORAL AB RLD, RS 1992-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020031-001 PAXIL EQ 10MG BASE TABLET / ORAL AB RLD 1992-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020031-002 PAXIL EQ 20MG BASE TABLET / ORAL AB RLD 1992-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020031-003 PAXIL EQ 30MG BASE TABLET / ORAL AB RLD 1992-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020031-004 PAXIL EQ 50MG BASE TABLET / ORAL 1992-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020031-005 PAXIL EQ 40MG BASE TABLET / ORAL AB RLD, RS 1992-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020031-001 PAXIL EQ 10MG BASE TABLET / ORAL AB RLD 1992-12-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020031-002 PAXIL EQ 20MG BASE TABLET / ORAL AB RLD 1992-12-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020031-003 PAXIL EQ 30MG BASE TABLET / ORAL AB RLD 1992-12-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020031-004 PAXIL EQ 50MG BASE TABLET / ORAL 1992-12-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020031-005 PAXIL EQ 40MG BASE TABLET / ORAL AB RLD, RS 1992-12-29 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PAROXETINE HYDROCHLORIDE HEMIHYDRATE ACTIVE INGREDIENT X2ELS050D8 PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP] 9 PAROXETINE ACTIVE MOIETY 41VRH5220H PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP] 9 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP] 9 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP] 9 DIMETHICONE 410 INACTIVE INGREDIENT TYU5GP6XGE PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP] 9 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP] 9 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP] 9 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP] 9 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP] 9 POLACRILIN POTASSIUM INACTIVE INGREDIENT 0BZ5A00FQU PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP] 9 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP] 9 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP] 9 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP] 9 SACCHARIN SODIUM ANHYDROUS INACTIVE INGREDIENT I4807BK602 PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP] 9 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP] 9 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP] 9 SORBITOL INACTIVE INGREDIENT 506T60A25R PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP] 9
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60505-3666-3 60505366603 30 TABLET, FILM COATED in 1 BOTTLE (60505-3666-3) 2011-01-01 2021-05-31 No No Current