Paroxetine

Product NDC
68071-2535
11-digit product format
680712535
Labeler code
68071
Product ID
68071-2535_49dcbbe1-ceb2-c8eb-e063-6394a90a9c5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharamceuticals, Inc.
Application
ANDA077584
Marketing category
ANDA
Marketing start
2007-04-13
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
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
A077584-001PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-03-07
A077584-002PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-03-07
A077584-003PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-03-07
A077584-004PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-03-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077584-001AB
A077584-002AB
A077584-003AB
A077584-004AB

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 UTC2026-02A077584-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077584-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077584-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077584-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-03-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077584-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077584-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077584-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077584-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-03-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077584-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077584-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077584-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077584-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-03-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077584-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077584-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077584-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077584-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-03-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077584-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-03-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077584-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-03-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077584-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-03-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077584-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-03-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077584-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-03-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077584-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-03-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077584-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-03-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077584-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-03-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077584-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-03-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077584-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-03-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077584-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-03-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077584-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-03-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077584-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-03-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077584-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-03-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077584-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-03-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077584-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-03-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077584-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-03-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077584-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-03-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077584-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-03-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077584-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-03-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077584-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-03-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A077584-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-03-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A077584-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-03-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A077584-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-03-07d06236e962d9…

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 UTC2026-02A077584-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077584-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077584-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077584-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077584-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077584-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077584-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077584-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077584-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077584-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077584-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077584-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077584-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077584-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077584-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077584-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077584-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077584-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077584-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077584-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077584-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077584-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077584-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077584-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077584-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077584-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077584-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077584-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077584-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077584-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077584-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077584-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077584-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077584-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077584-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077584-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077584-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077584-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077584-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077584-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Paroxetine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE10 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
1738483Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
49dc055c-faef-0be3-e063-6394a90a934fAvailable 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
68071-2535-9Paroxetine90 in 1 BOTTLETABLET, FILM COATED902

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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ParoxetinePAROXETINEREMEDYREPACK INC.679e4b9b-0f7b-450a-aca7-1b448cccbeed2026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEHAWAII REPACK, INC.d5206418-aa7f-42dd-b977-4b9d1e4b27522026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEAmerican Health Packagingb5a8f864-a53d-48d9-aca6-6b64017fb1682026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEREMEDYREPACK INC.05ec70fd-4c65-495f-ba12-e8433a10b6552026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEREMEDYREPACK INC.c002508e-f96c-413b-b232-5d55fceeffe02026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEREMEDYREPACK INC.bc0efd3b-c6b9-4ed0-b517-6e57e4700b7b2026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
PAROXETINEPAROXETINEDIRECT RX2cfe30fc-9c46-4efd-e054-00144ff8d46c2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEA-S Medication Solutions31e4bb7c-59ab-4cbf-ba08-317c1417b28f2026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEA-S Medication Solutionsa809a6b5-18a3-4771-aaf8-7197d17435402026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINENuCare Pharamceuticals, Inc.49dc055c-faef-0be3-e063-6394a90a934f2026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ndc (product): 68071-2535
ParoxetinePAROXETINEPD-Rx Pharmaceuticals, Inc.c0acc97d-3d8d-4a7f-8acd-99050b0af2f12025-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEPreferred Pharmaceuticals Inc.7d558598-6905-46da-8f34-668456c684112025-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc605c1d23-c97c-4ea4-92d0-fed351de9d2e2025-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEPreferred Pharmaceuticals Inc.ee38b589-e646-4203-bea5-cc3744fe17c32025-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEBryant Ranch Prepack0a0f8897-2099-4038-9b96-ed9c4f0840182025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEBryant Ranch Prepack7a702760-9b72-4595-bf47-01aff786c74d2025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEBryant Ranch Prepack07f245c5-fcb0-3008-d69e-10290cadbfa62025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEAsclemed USA, Inc.4acd3e7a-4f19-4428-9452-48ce370cb3db2025-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEDirect_Rxfea936a5-fdeb-e4fb-e053-6294a90a89952025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEZydus Pharmaceuticals USA Inc.a6bb4f0a-1555-4550-a7a4-99609674b1e72025-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSN49dc055c-faef-0be3-e063-6394a90a934f2
1738483paroxetine hydrochloride 10 MG Oral TabletSCD49dc055c-faef-0be3-e063-6394a90a934f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-2535-96807125350990 TABLET, FILM COATED in 1 BOTTLE (68071-2535-9) 2026-02-02NoNoCurrent