PAROXETINE

Product NDC
70518-1460
Requested package NDC
70518-1460-0
11-digit product format
705181460
Labeler code
70518
Product ID
70518-1460_4900bb35-ed0a-8189-e063-6294a90a9c82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075356
Marketing category
ANDA
Marketing start
2018-10-04
Substance
PAROXETINE HYDROCHLORIDE ANHYDROUS
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

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 packagepackage70518-146070518-1460-0DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…

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
A075356-001PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2003-07-30
A075356-002PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2003-07-30
A075356-003PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2003-07-30
A075356-004PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2003-07-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075356-001AB
A075356-002AB
A075356-003AB
A075356-004AB

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 UTC2026-02A075356-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2003-07-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075356-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2003-07-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075356-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2003-07-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075356-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2003-07-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075356-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2003-07-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075356-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2003-07-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075356-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2003-07-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075356-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2003-07-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A075356-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2003-07-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075356-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2003-07-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075356-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2003-07-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075356-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2003-07-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075356-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2003-07-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075356-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2003-07-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075356-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2003-07-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075356-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2003-07-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075356-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2003-07-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075356-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2003-07-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075356-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2003-07-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075356-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2003-07-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075356-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2003-07-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075356-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2003-07-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075356-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2003-07-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075356-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2003-07-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075356-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2003-07-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075356-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2003-07-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075356-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2003-07-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075356-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2003-07-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075356-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2003-07-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075356-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2003-07-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075356-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2003-07-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075356-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2003-07-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075356-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2003-07-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075356-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2003-07-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075356-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2003-07-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075356-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2003-07-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075356-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2003-07-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A075356-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2003-07-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A075356-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2003-07-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A075356-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2003-07-30d06236e962d9…

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 UTC2026-02A075356-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075356-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075356-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075356-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075356-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075356-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075356-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075356-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075356-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075356-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075356-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075356-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075356-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075356-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075356-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075356-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075356-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075356-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075356-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075356-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075356-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075356-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075356-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075356-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075356-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075356-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075356-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075356-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075356-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075356-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075356-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075356-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075356-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075356-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075356-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075356-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075356-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075356-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075356-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075356-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE ANHYDROUS30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3I3T11UD2SInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8e176ff2-ed3a-4909-94e1-6b9a3581a621Available 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
70518-1460-0PAROXETINE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9018
70518-1460-1PAROXETINE100 in 1 BOXTABLET, FILM COATED10018
70518-1460-2PAROXETINE1 in 1 POUCHTABLET, FILM COATED118

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1460PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC.]15Current NDC, Legacy NDC, 3 package rows20250429_8e176ff2-ed3a-4909-94e1-6b9a3581a621.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PAROXETINEPAROXETINE HYDROCHLORIDEREMEDYREPACK INC.8e176ff2-ed3a-4909-94e1-6b9a3581a6212026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075356
application number: ANDA075356
ndc (package): 70518-1460-0
ndc (product): 70518-1460
ndc11 (package): 70518146000
PAROXETINEPAROXETINE HYDROCHLORIDEREMEDYREPACK INC.beb87e2e-0a8f-43b6-b148-57f0b71915482026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075356
application number: ANDA075356
PAROXETINEPAROXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.e63fe922-b35a-406c-8737-f3f5e6d5a30d2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075356
application number: ANDA075356
PAROXETINEPAROXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4d3b4536-7900-223c-e063-6294a90a3d602026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075356
application number: ANDA075356
PAROXETINEPAROXETINE HYDROCHLORIDEREMEDYREPACK INC.98d4f767-06e3-4d9b-b1ad-4b31f7e361302026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075356
application number: ANDA075356
PAROXETINEPAROXETINE HYDROCHLORIDECardinal Health 107, LLC333dfd07-61f0-4b86-b4b5-b04adf64e49f2025-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075356
application number: ANDA075356
PAROXETINEPAROXETINE HYDROCHLORIDEMajor Pharmaceuticals84b1b1f0-d375-4fda-99af-9487f8ef50c72025-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075356
application number: ANDA075356
PAROXETINEPAROXETINE HYDROCHLORIDEApotex Corp.08320ea3-8f93-6f04-5d1c-f69af3eb5a812025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075356
application number: ANDA075356
PAROXETINEPAROXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC1801246b-02c3-430f-932a-b18cb0d13d1d2018-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075356
application number: ANDA075356
PAROXETINEPAROXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCa7128be7-7023-40c4-aa64-29d52145ae312018-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075356
application number: ANDA075356

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738503PARoxetine HCl 30 MG Oral TabletPSN8e176ff2-ed3a-4909-94e1-6b9a3581a62118
1738503paroxetine hydrochloride 30 MG Oral TabletSCD8e176ff2-ed3a-4909-94e1-6b9a3581a62118

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1460-07051814600090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1460-0) 2018-10-040000-00-00NoNoCurrent