Home NDC 60505-0402 PAXIL
Product NDC 60505-0402
11-digit product format 605050402
Labeler code 60505
Product ID 60505-0402_b9b9d7bd-6d4a-a0f1-36fa-3418c9de5a4f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name paroxetine hydrochloride
Dosage form SUSPENSION
Route ORAL
Labeler Apotex Corp
Application NDA020710
Marketing category NDA
Marketing start 2011-01-01
Marketing end 0000-00-00
Substance PAROXETINE HYDROCHLORIDE
Active strength 10 mg/5mL
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 4 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 60505-0402-5 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 60505-0402-5 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020710-001 PAXIL PAROXETINE HYDROCHLORIDE EQ 10MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUSPENSION / ORAL RLD 1997-06-25
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 2 · 42 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 N020710-001 PAXIL EQ 10MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUSPENSION / ORAL RLD 1997-06-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL RLD 1997-06-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL RLD 1997-06-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL RLD 1997-06-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL RLD 1997-06-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL RLD 1997-06-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL RLD 1997-06-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL RLD 1997-06-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL AB RLD, RS 1997-06-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL AB RLD, RS 1997-06-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL AB RLD, RS 1997-06-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL AB RLD, RS 1997-06-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL AB RLD, RS 1997-06-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL AB RLD, RS 1997-06-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL AB RLD, RS 1997-06-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL AB RLD, RS 1997-06-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL AB RLD, RS 1997-06-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL AB RLD, RS 1997-06-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL RLD, RS 1997-06-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL AB RLD, RS 1997-06-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL AB RLD, RS 1997-06-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL RLD, RS 1997-06-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL RLD, RS 1997-06-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL RLD, RS 1997-06-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL RLD, RS 1997-06-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL RLD, RS 1997-06-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL RLD, RS 1997-06-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL RLD, RS 1997-06-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL AB RLD, RS 1997-06-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL AB RLD, RS 1997-06-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL AB RLD, RS 1997-06-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL AB RLD, RS 1997-06-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL AB RLD, RS 1997-06-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL AB RLD, RS 1997-06-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL AB RLD, RS 1997-06-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL AB RLD, RS 1997-06-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL AB RLD, RS 1997-06-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL AB RLD, RS 1997-06-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL AB RLD, RS 1997-06-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020710-001 PAXIL EQ 10MG BASE/5ML SUSPENSION / ORAL AB RLD, RS 1997-06-25 e64feba35796…
Observed Orange Book normalized TE history# 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 Units Marketing start Marketing end Sample Exclude flag Status 60505-0402-5 60505040205 250 mL in 1 BOTTLE (60505-0402-5) 250 ml 2011-01-01 0000-00-00 No No Current