Home NDC 50090-0849-2 PAROXETINE
Product NDC 50090-0849
Requested package NDC 50090-0849-2
11-digit product format 500900849
Labeler code 50090
Product ID 50090-0849_4c1d0b43-d359-4b13-ab58-7f3b1b109f2d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name paroxetine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application ANDA075356
Marketing category ANDA
Marketing start 2003-09-08
Marketing end 0000-00-00
Substance PAROXETINE HYDROCHLORIDE ANHYDROUS
Active strength 20 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
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 · 180 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 2026-11-14 07:37:17 2026-10 A075356-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2003-07-30 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A075356-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2003-07-30 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A075356-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2003-07-30 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A075356-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2003-07-30 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A075356-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2003-07-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A075356-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2003-07-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A075356-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2003-07-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A075356-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2003-07-30 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 180 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 50090-0849-0 2023-01-30 C162847 48780-1 f386c649-be9f-0266-e053-dadaa90a7c1a PAROXETINE TABLETS, USP 10 mg, 20 mg, 30 mg and 40 mg Rx only 50090-0849-1 2023-01-30 C162847 48780-1 f386c649-be9f-0266-e053-dadaa90a7c1a PAROXETINE TABLETS, USP 10 mg, 20 mg, 30 mg and 40 mg Rx only 50090-0849-2 2023-01-30 C162847 48780-1 f386c649-be9f-0266-e053-dadaa90a7c1a PAROXETINE TABLETS, USP 10 mg, 20 mg, 30 mg and 40 mg Rx only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-0849-0 PAROXETINE 30 in 1 BOTTLE TABLET, FILM COATED 30 14 50090-0849-1 PAROXETINE 60 in 1 BOTTLE TABLET, FILM COATED 60 14 50090-0849-2 PAROXETINE 90 in 1 BOTTLE TABLET, FILM COATED 90 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-0849 PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 14 Legacy NDC, 3 package rows 20210611_83b19193-4db1-4365-a110-e8c67d792c21.zip
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 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 Marketing end Sample Exclude flag Status 50090-0849-2 50090084902 90 TABLET, FILM COATED in 1 BOTTLE (50090-0849-2) 2014-11-28 0000-00-00 No No Current