Paroxetine

Product NDC
68788-8777
11-digit product format
687888777
Labeler code
68788
Product ID
68788-8777_1a9c7947-4678-481e-b557-7ebf6dc04724
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride hemihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078902
Marketing category
ANDA
Marketing start
2025-01-01
Substance
PAROXETINE HYDROCHLORIDE
Active strength
20 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
A078902-001PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2008-03-13
A078902-002PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2008-03-13
A078902-003PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2008-03-13
A078902-004PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2008-03-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078902-001AB
A078902-002AB
A078902-003AB
A078902-004AB

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 UTC2026-02A078902-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2008-03-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078902-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2008-03-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078902-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2008-03-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078902-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2008-03-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078902-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2008-03-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078902-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2008-03-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078902-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2008-03-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078902-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2008-03-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A078902-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2008-03-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078902-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2008-03-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078902-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2008-03-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078902-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2008-03-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078902-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2008-03-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078902-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2008-03-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078902-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2008-03-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078902-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2008-03-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078902-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2008-03-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078902-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2008-03-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078902-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2008-03-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078902-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2008-03-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078902-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2008-03-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078902-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2008-03-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078902-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2008-03-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078902-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2008-03-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078902-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2008-03-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078902-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2008-03-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078902-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2008-03-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078902-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2008-03-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078902-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2008-03-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078902-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2008-03-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078902-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2008-03-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078902-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2008-03-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078902-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2008-03-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078902-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2008-03-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078902-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2008-03-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078902-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2008-03-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078902-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2008-03-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A078902-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2008-03-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A078902-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2008-03-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A078902-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2008-03-13d06236e962d9…

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 UTC2026-02A078902-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078902-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078902-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078902-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078902-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078902-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078902-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078902-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078902-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078902-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078902-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078902-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078902-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078902-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078902-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078902-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078902-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078902-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078902-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078902-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078902-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078902-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078902-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078902-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078902-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078902-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078902-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078902-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078902-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078902-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078902-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078902-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078902-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078902-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078902-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078902-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078902-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078902-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078902-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078902-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE20 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
2b2e6cd0-d779-4b7b-b3aa-85b796874ac3Available 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
68788-8777-1Paroxetine100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1002
68788-8777-3Paroxetine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
68788-8777-6Paroxetine60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
68788-8777-8Paroxetine120 in 1 BOTTLE, PLASTICTABLET, FILM COATED1202
68788-8777-9Paroxetine90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8777-1EA - Each68788-8777b067b236-db14-41ee-9ccc-cdbfaaf2b60612025-02-10
68788-8777-3EA - Each68788-87779e17e238-9cab-4be1-9590-0319e384f9a312025-02-10
68788-8777-6EA - Each68788-8777859e36b9-3f4a-4cf8-8c6c-40efdf42429712025-02-10
68788-8777-8EA - Each68788-877784f3f835-6e45-42e0-9100-718bcceb545d12025-02-10
68788-8777-9EA - Each68788-87771585e163-baf9-409a-b624-b49b09bd9e2312025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8777PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20250101_2b2e6cd0-d779-4b7b-b3aa-85b796874ac3.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEPD-Rx Pharmaceuticals, Inc.619e10bb-6e5d-4ec3-a85a-6270965f53892026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078902
application number: ANDA078902
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEPD-Rx Pharmaceuticals, Inc.ff7c7e20-c9ee-4693-beaa-7ac532d5c4b72026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078902
application number: ANDA078902
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEMylan Pharmaceuticals Inc.89dd7e24-85fc-4152-89ea-47ec2b48a1ed2026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078902
application number: ANDA078902
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEPreferred Pharmaceuticals Inc.2b2e6cd0-d779-4b7b-b3aa-85b796874ac32026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078902
application number: ANDA078902
ndc (product): 68788-8777
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEAphena Pharma Solutions - Tennessee, LLCec9622ca-1f56-4216-9445-485791c4c0ed2020-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078902
application number: ANDA078902
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEAphena Pharma Solutions - Tennessee, LLC45ef7ce8-5aa0-488c-a81c-cdfbda66ac042019-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078902
application number: ANDA078902
ParoxetinePAROXETINE HYDROCHLORIDE HEMIHYDRATEAphena Pharma Solutions - Tennessee, LLC2eebd2b6-7c64-45ca-8eb5-5201137f610a2018-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078902
application number: ANDA078902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738495PARoxetine HCl 20 MG Oral TabletPSN2b2e6cd0-d779-4b7b-b3aa-85b796874ac32
1738495paroxetine hydrochloride 20 MG Oral TabletSCD2b2e6cd0-d779-4b7b-b3aa-85b796874ac32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8777-168788877701100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8777-1) 2025-01-01NoNoCurrent
68788-8777-36878887770330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8777-3) 2025-01-01NoNoCurrent
68788-8777-66878887770660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8777-6) 2025-01-01NoNoCurrent
68788-8777-868788877708120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8777-8) 2025-01-01NoNoCurrent
68788-8777-96878887770990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8777-9) 2025-01-01NoNoCurrent