Paroxetine

Product NDC
50268-642
11-digit product format
502680642
Labeler code
50268
Product ID
50268-642_4dc86e5a-77b7-8cfe-e063-6394a90a7289
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA078406
Marketing category
ANDA
Marketing start
2016-03-11
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
30 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE30 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1738483Internal RxNorm lookup
1738495Internal RxNorm lookup
1738503Internal RxNorm lookup
1738511Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9a5e0aa-e638-5d6e-75c2-20cb78fc4f43Available 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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-02-03Paroxetine Tablets, USP
2022-02-03Paroxetine Tablets, USP
2022-01-28Paroxetine Tablets, USP
2022-01-28Paroxetine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-642-11Paroxetine1 in 1 BLISTER PACKTABLET, FILM COATED19
50268-642-15Paroxetine50 in 1 BOX, UNIT-DOSETABLET, FILM COATED509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-642-11EA - Each50268-642d6da5768-c65d-4e8e-b290-95195217637712016-04-04
50268-642-15EA - Each50268-6429e097ffb-25b2-4478-ae4c-1faae6607f6f12016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-642PAROXETINE TABLET, FILM COATED [AVPAK]7Current NDC, Legacy NDC, 2 package rows20220507_d9a5e0aa-e638-5d6e-75c2-20cb78fc4f43.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
ndc (product): 50268-642
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
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
1738483PARoxetine HCl 10 MG Oral TabletPSNd9a5e0aa-e638-5d6e-75c2-20cb78fc4f439
1738495PARoxetine HCl 20 MG Oral TabletPSNd9a5e0aa-e638-5d6e-75c2-20cb78fc4f439
1738503PARoxetine HCl 30 MG Oral TabletPSNd9a5e0aa-e638-5d6e-75c2-20cb78fc4f439
1738511PARoxetine HCl 40 MG Oral TabletPSNd9a5e0aa-e638-5d6e-75c2-20cb78fc4f439
1738483paroxetine hydrochloride 10 MG Oral TabletSCDd9a5e0aa-e638-5d6e-75c2-20cb78fc4f439
1738495paroxetine hydrochloride 20 MG Oral TabletSCDd9a5e0aa-e638-5d6e-75c2-20cb78fc4f439
1738503paroxetine hydrochloride 30 MG Oral TabletSCDd9a5e0aa-e638-5d6e-75c2-20cb78fc4f439
1738511paroxetine hydrochloride 40 MG Oral TabletSCDd9a5e0aa-e638-5d6e-75c2-20cb78fc4f439

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-642-11502680642111 in 1 BLISTER PACKHistorical
50268-642-155026806421550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-642-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-642-11) 50 blister pack2016-03-110000-00-00NoNoCurrent