Home NDC 60505-3666-3 PAXIL
Product NDC 60505-3666
Requested package NDC 60505-3666-3
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 215 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 2026-09-14 22:38:34 2026-08 N020031-001 PAXIL EQ 10MG BASE TABLET / ORAL AB RLD 1992-12-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020031-002 PAXIL EQ 20MG BASE TABLET / ORAL AB RLD 1992-12-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020031-003 PAXIL EQ 30MG BASE TABLET / ORAL AB RLD 1992-12-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020031-004 PAXIL EQ 50MG BASE TABLET / ORAL 1992-12-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020031-005 PAXIL EQ 40MG BASE TABLET / ORAL AB RLD, RS 1992-12-29 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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