Home NDC 71610-992 PAROXETINE
Product NDC 71610-992
11-digit product format 716100992
Labeler code 71610
Product ID 71610-992_4d3b40a4-5332-7664-e063-6394a90aed00
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name paroxetine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA075356
Marketing category ANDA
Marketing start 2003-07-30
Substance PAROXETINE HYDROCHLORIDE ANHYDROUS
Active strength 40 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075356-001 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2003-07-30 A075356-002 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2003-07-30 A075356-003 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2003-07-30 A075356-004 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2003-07-30
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 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 A075356-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2003-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075356-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2003-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075356-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2003-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075356-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2003-07-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075356-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2003-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075356-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2003-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075356-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2003-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075356-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2003-07-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075356-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2003-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075356-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2003-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075356-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2003-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075356-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2003-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075356-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2003-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075356-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2003-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075356-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2003-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075356-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2003-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075356-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2003-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075356-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2003-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075356-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2003-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075356-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2003-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075356-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2003-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075356-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2003-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075356-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2003-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075356-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2003-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075356-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2003-07-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075356-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2003-07-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075356-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2003-07-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075356-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2003-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075356-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2003-07-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075356-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2003-07-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075356-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2003-07-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075356-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2003-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075356-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2003-07-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075356-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2003-07-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075356-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2003-07-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075356-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2003-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075356-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2003-07-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075356-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2003-07-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075356-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2003-07-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075356-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2003-07-30 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 2 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 PAROXETINE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PAROXETINE HYDROCHLORIDE ANHYDROUS 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3I3T11UD2S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1738511 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71610-992-30 PAROXETINE 30 in 1 BOTTLE TABLET, FILM COATED 30 1 71610-992-45 PAROXETINE 45 in 1 BOTTLE TABLET, FILM COATED 45 1 71610-992-53 PAROXETINE 60 in 1 BOTTLE TABLET, FILM COATED 60 1 71610-992-60 PAROXETINE 90 in 1 BOTTLE TABLET, FILM COATED 90 1
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PAROXETINE PAROXETINE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 4d3b4536-7900-223c-e063-6294a90a3d60 2026-03-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075356 application number: ANDA075356 ndc (product): 71610-992 PAROXETINE PAROXETINE HYDROCHLORIDE Cardinal Health 107, LLC 333dfd07-61f0-4b86-b4b5-b04adf64e49f 2025-08-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075356 application number: ANDA075356 PAROXETINE PAROXETINE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 1801246b-02c3-430f-932a-b18cb0d13d1d 2018-11-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075356 application number: ANDA075356 PAROXETINE PAROXETINE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC a7128be7-7023-40c4-aa64-29d52145ae31 2018-10-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075356 application number: ANDA075356
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71610-992-30 71610099230 30 TABLET, FILM COATED in 1 BOTTLE (71610-992-30) 2026-03-17 No No Current 71610-992-45 71610099245 45 TABLET, FILM COATED in 1 BOTTLE (71610-992-45) 2026-03-17 No No Current 71610-992-53 71610099253 60 TABLET, FILM COATED in 1 BOTTLE (71610-992-53) 2026-03-17 No No Current 71610-992-60 71610099260 90 TABLET, FILM COATED in 1 BOTTLE (71610-992-60) 2026-03-17 No No Current