Paroxetine

Product NDC
16714-181
11-digit product format
167140181
Labeler code
16714
Product ID
16714-181_0e3542cb-82a1-4a53-b814-55cfa4075ba6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA078406
Marketing category
ANDA
Marketing start
2007-07-25
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
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage16714-18116714-181-03DDiscontinued 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
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 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 · 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
118320de-0632-4139-8b13-7428b41da0acAvailable 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
16714-181-01Paroxetine30 in 1 BOTTLETABLET, FILM COATED305
16714-181-02Paroxetine90 in 1 BOTTLETABLET, FILM COATED905
16714-181-03Paroxetine100 in 1 BOTTLETABLET, FILM COATED1005
16714-181-04Paroxetine500 in 1 BOTTLETABLET, FILM COATED5005
16714-181-05Paroxetine1000 in 1 BOTTLETABLET, FILM COATED10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-181-01EA - Each16714-1814d8e385d-d40c-47e5-a1f1-65b43cc39dca12022-03-09
16714-181-02EA - Each16714-181b3781dc2-ae46-41f1-b4c5-e4da3856799812022-03-09
16714-181-03EA - Each16714-18162c3324f-835d-436b-8a8b-95d23d83624a12022-03-09
16714-181-04EA - Each16714-1815397ab0a-3d9b-407b-9076-b34b9eec416612022-03-09
16714-181-05EA - Each16714-18144a8367e-6b7e-4734-9d04-45c63d579b6312022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-181PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [NORTHSTAR RX LLC]4Current NDC, Legacy NDC, 5 package rows20250410_118320de-0632-4139-8b13-7428b41da0ac.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
ndc (product): 16714-181
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
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 TabletPSN118320de-0632-4139-8b13-7428b41da0ac5
1738495PARoxetine HCl 20 MG Oral TabletPSN118320de-0632-4139-8b13-7428b41da0ac5
1738503PARoxetine HCl 30 MG Oral TabletPSN118320de-0632-4139-8b13-7428b41da0ac5
1738511PARoxetine HCl 40 MG Oral TabletPSN118320de-0632-4139-8b13-7428b41da0ac5
1738483paroxetine hydrochloride 10 MG Oral TabletSCD118320de-0632-4139-8b13-7428b41da0ac5
1738495paroxetine hydrochloride 20 MG Oral TabletSCD118320de-0632-4139-8b13-7428b41da0ac5
1738503paroxetine hydrochloride 30 MG Oral TabletSCD118320de-0632-4139-8b13-7428b41da0ac5
1738511paroxetine hydrochloride 40 MG Oral TabletSCD118320de-0632-4139-8b13-7428b41da0ac5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-181-011671401810130 TABLET, FILM COATED in 1 BOTTLE (16714-181-01) 2007-07-250000-00-00NoNoCurrent
16714-181-021671401810290 TABLET, FILM COATED in 1 BOTTLE (16714-181-02) 2007-07-250000-00-00NoNoCurrent
16714-181-0316714018103100 TABLET, FILM COATED in 1 BOTTLE (16714-181-03) 2007-07-250000-00-00NoNoCurrent
16714-181-0416714018104500 TABLET, FILM COATED in 1 BOTTLE (16714-181-04) 2007-07-250000-00-00NoNoCurrent
16714-181-05167140181051000 TABLET, FILM COATED in 1 BOTTLE (16714-181-05) 2007-07-250000-00-00NoNoCurrent