Paroxetine

Product NDC
60760-398
11-digit product format
607600398
Labeler code
60760
Product ID
60760-398_85020df0-53d9-0509-e053-2991aa0ad800
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA077584
Marketing category
ANDA
Marketing start
2019-03-20
Marketing end
0000-00-00
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
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60760-398DDiscontinued by firm2026-08-03
excluded packagepackage60760-39860760-398-90DDiscontinued by firm2026-08-03

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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-398-90EA - Each60760-398ef9ce5e7-7013-49ee-b9f1-a079a53fca5012019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-398PAROXETINE TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]1Legacy NDC20190329_85020965-cd8d-8325-e053-2a91aa0a7015.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 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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-398-906076003989090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-398-90) 2019-03-200000-00-00NoNoCurrent