Home NDC 57664-425 Paroxetine
Product NDC 57664-425
11-digit product format 576640425
Labeler code 57664
Product ID 57664-425_38e34831-580e-4773-a1a8-7358fee2424e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Paroxetine
Dosage form TABLET
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA078194
Marketing category ANDA
Marketing start 2007-06-29
Marketing end 0000-00-00
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 2019-12-31
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 2 · 72 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078194-001 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2007-06-29 A078194-002 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2007-06-29 A078194-003 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2007-06-29 A078194-004 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL 2007-06-29
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 5 · 172 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 A078194-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2007-06-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078194-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2007-06-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078194-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2007-06-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078194-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL 2007-06-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078194-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2007-06-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078194-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2007-06-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078194-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2007-06-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078194-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL 2007-06-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078194-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2007-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078194-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2007-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078194-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2007-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078194-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL 2007-06-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078194-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2007-06-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078194-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2007-06-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078194-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2007-06-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078194-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL 2007-06-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078194-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2007-06-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078194-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2007-06-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078194-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2007-06-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078194-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL 2007-06-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078194-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2007-06-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078194-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2007-06-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078194-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2007-06-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078194-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL 2007-06-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078194-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2007-06-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078194-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2007-06-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078194-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2007-06-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078194-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL 2007-06-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078194-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2007-06-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078194-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2007-06-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078194-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2007-06-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078194-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL 2007-06-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078194-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2007-06-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078194-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2007-06-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078194-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2007-06-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078194-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL 2007-06-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078194-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2007-06-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078194-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2007-06-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078194-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2007-06-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078194-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL 2007-06-29 5bbf6a4d5a75…
Observed Orange Book normalized TE history# 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 PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 6 PAROXETINE ACTIVE MOIETY 41VRH5220H PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 6 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 6 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 6 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 6 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 6 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 6 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 6 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 6 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 6 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 6