Home NDC 66116-434 Paroxetine
Product NDC 66116-434
11-digit product format 661160434
Labeler code 66116
Product ID 66116-434_b1894876-1824-4f87-95ed-d2a805683e15
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Paroxetine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler MedVantx, Inc.
Application ANDA076618
Marketing category ANDA
Marketing start 2005-10-03
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 E
Listing certified through 2017-12-31
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 66116-434-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 66116-434-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 66116-434-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 66116-434-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 66116-434-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 66116-434-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 66116-434-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 66116-434-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 66116-434-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 66116-434-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 66116-434-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 66116-434-30 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 66116-434-30 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 66116-434-30 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 66116-434-30 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 66116-434-30 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 66116-434-30 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 66116-434-30 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 66116-434-30 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 66116-434-30 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 66116-434-30 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 66116-434-30 110d247fa046…a55b01930146…
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 A076618-001 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-08-15 A076618-002 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-08-15 A076618-003 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2005-08-15 A076618-004 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-08-15
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 A076618-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076618-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076618-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2005-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076618-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-08-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076618-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076618-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076618-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2005-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076618-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-08-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076618-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076618-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076618-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2005-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076618-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-08-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076618-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076618-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076618-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2005-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076618-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-08-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076618-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076618-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076618-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2005-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076618-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-08-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076618-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076618-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076618-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2005-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076618-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-08-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076618-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-08-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076618-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-08-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076618-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2005-08-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076618-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-08-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076618-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-08-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076618-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-08-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076618-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2005-08-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076618-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-08-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076618-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-08-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076618-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-08-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076618-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2005-08-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076618-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-08-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076618-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-08-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076618-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-08-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076618-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2005-08-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076618-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-08-15 5bbf6a4d5a75…
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.
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 66116-434-30 Paroxetine 30 in 1 BOTTLE TABLET, FILM COATED 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PAROXETINE HYDROCHLORIDE ANHYDROUS ACTIVE INGREDIENT 3I3T11UD2S PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [MEDVANTX, INC.] 1 PAROXETINE ACTIVE MOIETY 41VRH5220H PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [MEDVANTX, INC.] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [MEDVANTX, INC.] 1 CALCIUM PHOSPHATE INACTIVE INGREDIENT 97Z1WI3NDX PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [MEDVANTX, INC.] 1 COCHINEAL INACTIVE INGREDIENT TZ8Z31B35M PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [MEDVANTX, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [MEDVANTX, INC.] 1 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [MEDVANTX, INC.] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [MEDVANTX, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [MEDVANTX, INC.] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [MEDVANTX, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [MEDVANTX, INC.] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [MEDVANTX, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [MEDVANTX, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [MEDVANTX, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66116-434 PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [MEDVANTX, INC.] 1 Legacy NDC, 1 package rows 20130608_b1894876-1824-4f87-95ed-d2a805683e15.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 66116-434-30 66116043430 30 in 1 BOTTLE Historical