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 firm2026-10-15
excluded packagepackage57664-42157664-421-08DDiscontinued by firm2026-10-15
excluded packagepackage57664-42157664-421-13DDiscontinued by firm2026-10-15
excluded packagepackage57664-42157664-421-18DDiscontinued by firm2026-10-15
excluded packagepackage57664-42157664-421-83DDiscontinued by firm2026-10-15
excluded packagepackage57664-42157664-421-99DDiscontinued by firm2026-10-15

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 2 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
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57664-421-13367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57664-421-99367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57664-421-83367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57664-421-08367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57664-421-18367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57664-421-13557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57664-421-99557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57664-421-83557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57664-421-08557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57664-421-18557ba5c1ecfa…9c80585c8c6e…

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-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 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A078194-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2007-06-29c2088c7a36db…
2026-10-15 13:18:302026-09A078194-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2007-06-29c2088c7a36db…
2026-10-15 13:18:302026-09A078194-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2007-06-29c2088c7a36db…
2026-10-15 13:18:302026-09A078194-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2007-06-29c2088c7a36db…
2026-09-14 22:38:342026-08A078194-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2007-06-2984e616aacf4f…
2026-09-14 22:38:342026-08A078194-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2007-06-2984e616aacf4f…
2026-09-14 22:38:342026-08A078194-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2007-06-2984e616aacf4f…
2026-09-14 22:38:342026-08A078194-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2007-06-2984e616aacf4f…
2026-08-18 06:07:402026-07A078194-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2007-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A078194-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2007-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A078194-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2007-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A078194-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2007-06-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078194-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2007-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078194-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2007-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078194-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2007-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078194-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2007-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078194-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2007-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078194-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2007-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078194-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2007-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078194-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2007-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A078194-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2007-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078194-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2007-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078194-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2007-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078194-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2007-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078194-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2007-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078194-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2007-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078194-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2007-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078194-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2007-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078194-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2007-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078194-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2007-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078194-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2007-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078194-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2007-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078194-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2007-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078194-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2007-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078194-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2007-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078194-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2007-06-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078194-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2007-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078194-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2007-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078194-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2007-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078194-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORAL2007-06-292680178bc6a6…

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