PAROXETINE

Product NDC
0904-5676
11-digit product format
009045676
Labeler code
0904
Product ID
0904-5676_9a171d3f-aa1b-4120-82ee-af67f33f167f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA075356
Marketing category
ANDA
Marketing start
2003-09-08
Substance
PAROXETINE HYDROCHLORIDE ANHYDROUS
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

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE ANHYDROUS10 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 · 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
84b1b1f0-d375-4fda-99af-9487f8ef50c7Available 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
0904-5676-61PAROXETINE1 in 1 BLISTER PACKTABLET, FILM COATED119
0904-5676-61PAROXETINE100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5676-61EA - Each0904-567649e514af-02dd-49cc-bfef-4a21670b993212012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-5676PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]17Current NDC, Legacy NDC, 2 package rows20250213_84b1b1f0-d375-4fda-99af-9487f8ef50c7.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
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
ndc (product): 0904-5676
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
1738483PARoxetine HCl 10 MG Oral TabletPSN84b1b1f0-d375-4fda-99af-9487f8ef50c719
1738495PARoxetine HCl 20 MG Oral TabletPSN84b1b1f0-d375-4fda-99af-9487f8ef50c719
1738503PARoxetine HCl 30 MG Oral TabletPSN84b1b1f0-d375-4fda-99af-9487f8ef50c719
1738511PARoxetine HCl 40 MG Oral TabletPSN84b1b1f0-d375-4fda-99af-9487f8ef50c719
1738483paroxetine hydrochloride 10 MG Oral TabletSCD84b1b1f0-d375-4fda-99af-9487f8ef50c719
1738495paroxetine hydrochloride 20 MG Oral TabletSCD84b1b1f0-d375-4fda-99af-9487f8ef50c719
1738503paroxetine hydrochloride 30 MG Oral TabletSCD84b1b1f0-d375-4fda-99af-9487f8ef50c719
1738511paroxetine hydrochloride 40 MG Oral TabletSCD84b1b1f0-d375-4fda-99af-9487f8ef50c719

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5676-6100904567661100 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-5676-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2003-09-080000-00-00NoNoCurrent