Home NDC 61919-322 PAROXETINE
Product NDC 61919-322
11-digit product format 619190322
Labeler code 61919
Product ID 61919-322_f2152dab-c7ce-3e59-e053-2995a90a3120
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PAROXETINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler DIRECT RX
Application ANDA075356
Marketing category ANDA
Marketing start 2014-01-01
Marketing end 0000-00-00
Substance PAROXETINE HYDROCHLORIDE ANHYDROUS
Active strength 10 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2024-12-31
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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61919-322-30 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61919-322-30 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61919-322-30 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61919-322-30 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61919-322-30 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61919-322-30 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61919-322-30 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61919-322-30 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61919-322-30 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 176 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 2026-10-15 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…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…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 5 · 176 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61919-322-30 PAROXETINE 30 in 1 BOTTLE TABLET, FILM COATED 30 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PAROXETINE HYDROCHLORIDE ANHYDROUS ACTIVE INGREDIENT 3I3T11UD2S PAROXETINE TABLET, FILM COATED [DIRECT RX] 1 PAROXETINE ACTIVE MOIETY 41VRH5220H PAROXETINE TABLET, FILM COATED [DIRECT RX] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PAROXETINE TABLET, FILM COATED [DIRECT RX] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P PAROXETINE TABLET, FILM COATED [DIRECT RX] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PAROXETINE TABLET, FILM COATED [DIRECT RX] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PAROXETINE TABLET, FILM COATED [DIRECT RX] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PAROXETINE TABLET, FILM COATED [DIRECT RX] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 PAROXETINE TABLET, FILM COATED [DIRECT RX] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAROXETINE TABLET, FILM COATED [DIRECT RX] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61919-322 PAROXETINE TABLET, FILM COATED [DIRECT RX] 9 Legacy NDC, 1 package rows 20230511_fce8fb27-554b-43e2-8ec9-fc4ca0b0ab8b.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 61919-322-30 61919032230 30 TABLET, FILM COATED in 1 BOTTLE (61919-322-30) 2015-01-01 0000-00-00 No No Current