Paroxetine

Product NDC
63187-564
11-digit product format
631870564
Labeler code
63187
Product ID
63187-564_4637d56c-fd38-47ea-b814-4d87a7d36f1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078406
Marketing category
ANDA
Marketing start
2009-12-03
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
20 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078406-001PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-07-25
A078406-002PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-07-25
A078406-003PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-07-25
A078406-004PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-07-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A078406-001AB
A078406-002AB
A078406-003AB
A078406-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078406-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078406-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078406-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078406-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-07-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078406-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-07-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078406-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-07-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078406-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-07-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078406-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-07-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078406-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-07-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078406-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-07-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078406-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-07-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078406-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-07-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078406-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-07-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078406-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-07-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078406-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-07-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078406-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-07-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078406-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-07-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078406-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-07-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078406-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-07-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078406-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-07-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078406-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-07-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078406-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-07-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078406-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-07-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078406-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-07-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078406-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-07-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078406-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-07-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078406-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-07-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078406-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-07-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078406-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-07-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078406-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-07-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078406-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-07-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078406-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-07-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078406-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-07-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078406-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-07-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078406-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-07-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078406-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-07-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078406-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-07-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A078406-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-07-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A078406-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-07-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A078406-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-07-25d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078406-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078406-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078406-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078406-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078406-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078406-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078406-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078406-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078406-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078406-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078406-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078406-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078406-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078406-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078406-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078406-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078406-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078406-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078406-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078406-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078406-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078406-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078406-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078406-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078406-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078406-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078406-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078406-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078406-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078406-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078406-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078406-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078406-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078406-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078406-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078406-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078406-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078406-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078406-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078406-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Paroxetine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X2ELS050D8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1738495Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
847118ec-c139-466c-834b-1ae0b6e1f791Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ace441e-5ed1-9a56-64e5-302d887093bdProduct name720250107
ba9fc237-0e76-4ac8-d3c5-cdb4df9e9f7fProduct name420220524
200c61bf-0879-1df7-72b7-b72a8497b114Product name320171006
b430fc19-562d-420b-53a2-64d42b938631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-564-30Paroxetine30 in 1 BOTTLETABLET, FILM COATED303
63187-564-60Paroxetine60 in 1 BOTTLETABLET, FILM COATED603
63187-564-90Paroxetine90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PAROXETINE HYDROCHLORIDE HEMIHYDRATEACTIVE INGREDIENTX2ELS050D8PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]1
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JPAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPPAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BPAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-564PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20210113_847118ec-c139-466c-834b-1ae0b6e1f791.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ParoxetinePAROXETINEREMEDYREPACK INC.f52ca1fc-fbf7-4b2b-9e74-975c310b8ce62026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078406
application number: ANDA078406
ParoxetinePAROXETINE HYDROCHLORIDENorthStar Rx LLC118320de-0632-4139-8b13-7428b41da0ac2026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078406
application number: ANDA078406
ParoxetinePAROXETINEAvPAKd9a5e0aa-e638-5d6e-75c2-20cb78fc4f432026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078406
application number: ANDA078406
ParoxetinePAROXETINEAurolife Pharma LLCe1ea4019-bb66-403c-a3d5-6ae056a591162025-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078406
application number: ANDA078406
ParoxetinePAROXETINE HYDROCHLORIDEAurobindo Pharma Limited326e8ab0-6886-4749-9544-885b370700512025-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078406
application number: ANDA078406
ParoxetinePAROXETINENCS HealthCare of KY, LLC dba Vangard Labs0a8a58c7-5008-4c65-ae0e-e4ee809b18072022-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078406
application number: ANDA078406
ParoxetinePAROXETINEProficient Rx LP847118ec-c139-466c-834b-1ae0b6e1f7912021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078406
application number: ANDA078406
ndc (product): 63187-564
ParoxetinePAROXETINEAphena Pharma Solutions - Tennessee, LLC662223ec-3b9b-4a85-9680-789522363a7b2018-07-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078406
application number: ANDA078406
ParoxetinePAROXETINEAphena Pharma Solutions - Tennessee, LLC30fd2fc4-f661-44c9-a9a9-9d0de0892e3c2018-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078406
application number: ANDA078406

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738495PARoxetine HCl 20 MG Oral TabletPSN847118ec-c139-466c-834b-1ae0b6e1f7913
1738495paroxetine hydrochloride 20 MG Oral TabletSCD847118ec-c139-466c-834b-1ae0b6e1f7913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-564-306318705643030 TABLET, FILM COATED in 1 BOTTLE (63187-564-30) 2018-12-010000-00-00NoNoCurrent
63187-564-606318705646060 TABLET, FILM COATED in 1 BOTTLE (63187-564-60) 2018-12-010000-00-00NoNoCurrent
63187-564-906318705649090 TABLET, FILM COATED in 1 BOTTLE (63187-564-90) 2018-12-010000-00-00NoNoCurrent