Home NDC 60505-4519 PAXIL
Product NDC 60505-4519
11-digit product format 605054519
Labeler code 60505
Product ID 60505-4519_e1aa474e-4ffe-6c6c-8037-84907819bb88
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 30 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base PAXIL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PAROXETINE HYDROCHLORIDE 30 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-4519-3 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 60505-4519 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 60505-4519-3 60505451903 30 TABLET, FILM COATED in 1 BOTTLE (60505-4519-3) 2019-03-11 0000-00-00 No No Current