Paroxetine

Product NDC
57664-421
11-digit product format
576640421
Labeler code
57664
Product ID
57664-421_38e34831-580e-4773-a1a8-7358fee2424e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA078194
Marketing category
ANDA
Marketing start
2007-06-29
Marketing end
0000-00-00
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
10 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57664-421DDiscontinued by firm2026-10-12
excluded packagepackage57664-42157664-421-08DDiscontinued by firm2026-10-12
excluded packagepackage57664-42157664-421-13DDiscontinued by firm2026-10-12
excluded packagepackage57664-42157664-421-18DDiscontinued by firm2026-10-12
excluded packagepackage57664-42157664-421-83DDiscontinued by firm2026-10-12
excluded packagepackage57664-42157664-421-99DDiscontinued by firm2026-10-12

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 2 · 72 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-421-13d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-421-99d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-421-83d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-421-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-421-18d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-421-13f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-421-99f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-421-83f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-421-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-421-18f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-421-132ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-421-992ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-421-832ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-421-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-421-182ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-421-13a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-421-99a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-421-83a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-421-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-421-18a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-421-13cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-421-99cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-421-83cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-421-08cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-421-18cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-421-13cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-421-99cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-421-83cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-421-08cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-421-18cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-421-13302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-421-99302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-421-83302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-421-08302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-421-18302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-421-13ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-421-99ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-421-83ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-421-08ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-421-18ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-421-130efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-421-990efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-421-830efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-421-080efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-421-180efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-421-13ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-421-99ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-421-83ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-421-08ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-421-18ad56d346431e…cc804d4bbf1e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078194-001PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2007-06-29
A078194-002PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2007-06-29
A078194-003PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2007-06-29
A078194-004PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2007-06-29

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 4 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-02-18 07:12 UTC2024-02A078194-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2007-06-291c564ffb4f44…
2024-02-18 07:12 UTC2024-02A078194-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2007-06-291c564ffb4f44…
2024-02-18 07:12 UTC2024-02A078194-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2007-06-291c564ffb4f44…
2024-02-18 07:12 UTC2024-02A078194-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2007-06-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078194-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2007-06-29ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A078194-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2007-06-29ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A078194-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2007-06-29ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A078194-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2007-06-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078194-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2007-06-29a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078194-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2007-06-29a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078194-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2007-06-29a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078194-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2007-06-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078194-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2007-06-299b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078194-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2007-06-299b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078194-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2007-06-299b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078194-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2007-06-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078194-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2007-06-29a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078194-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2007-06-29a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078194-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2007-06-29a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078194-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2007-06-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078194-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2007-06-293f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078194-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2007-06-293f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078194-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2007-06-293f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078194-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2007-06-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A078194-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2007-06-29053a50430f4f…
2023-05-13 08:27 UTC2023-05A078194-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2007-06-29053a50430f4f…
2023-05-13 08:27 UTC2023-05A078194-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2007-06-29053a50430f4f…
2023-05-13 08:27 UTC2023-05A078194-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2007-06-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A078194-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2007-06-293bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A078194-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2007-06-293bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A078194-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2007-06-293bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A078194-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2007-06-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078194-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2007-06-293a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078194-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2007-06-293a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078194-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2007-06-293a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078194-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2007-06-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078194-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2007-06-29f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A078194-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2007-06-29f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A078194-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2007-06-29f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A078194-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2007-06-29f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A078194-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A078194-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A078194-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A078194-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078194-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A078194-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A078194-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A078194-004AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-421-13EA - Each57664-421a159c85a-bedc-40f7-ae48-c7237bea5bcc12013-02-13
57664-421-83EA - Each57664-421dc6d3c8a-d1c4-488b-be81-0b180246613b12013-02-13
57664-421-99EA - Each57664-4210c8e9eef-75c7-4293-b4d5-2cc63022c8d512013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PAROXETINE HYDROCHLORIDE HEMIHYDRATEACTIVE INGREDIENTX2ELS050D8PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6