FDA.reportPublic FDA data

paroxetine hydrochloride

Product NDC
69584-672
11-digit product format
695840672
Labeler code
69584
Product ID
69584-672_2ac7f06f-af78-4705-a209-d9041b2de825
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Oxford Pharmaceuticals, LLC
Application
ANDA076968
Marketing category
ANDA
Marketing start
2022-11-14
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
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
A076968-001PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2010-06-21
A076968-002PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2010-06-21
A076968-003PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2010-06-21
A076968-004PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2010-06-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076968-001AB
A076968-002AB
A076968-003AB
A076968-004AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A076968-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2010-06-21a50c72e98297…
2026-08-01 22:54:322026-06A076968-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2010-06-21a50c72e98297…
2026-08-01 22:54:322026-06A076968-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2010-06-21a50c72e98297…
2026-08-01 22:54:322026-06A076968-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2010-06-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076968-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A076968-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A076968-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A076968-004AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
paroxetine hydrochloridePAROXETINE HYDROCHLORIDEBryant Ranch Prepackc3c204df-6b7d-42fb-8794-4f38064ed9632024-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076968
application number: ANDA076968
paroxetine hydrochloridePAROXETINE HYDROCHLORIDEOxford Pharmaceuticals, LLC25182b68-8f7a-48e8-9788-6818b0984b292024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076968
application number: ANDA076968
ndc (product): 69584-672

Additional Listing Data#

Finished product
Yes
Brand name base
paroxetine hydrochloride
Listing expiration
2026-12-31

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 · 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
25182b68-8f7a-48e8-9788-6818b0984b29Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ace441e-5ed1-9a56-64e5-302d887093bdProduct name720250107
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
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
69584-672-03paroxetine hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
69584-672-09paroxetine hydrochloride90 in 1 BOTTLETABLET, FILM COATED902
69584-672-10paroxetine hydrochloride100 in 1 BOTTLETABLET, FILM COATED1002
69584-672-50paroxetine hydrochloride500 in 1 BOTTLETABLET, FILM COATED5002
69584-672-90paroxetine hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69584-672-03EA - Each69584-672d5cbd903-770a-4fa0-809a-ddce9764d98c12022-12-07
69584-672-09EA - Each69584-6725bc72e9c-fd0c-42ed-bd26-ca4c5091cfff12022-12-07
69584-672-10EA - Each69584-67249fc6930-bd11-49e5-9a7e-e9c7bc5b667c12022-12-07
69584-672-50EA - Each69584-67259eafb7e-29de-4951-bb6e-4b6359b0d5f712022-12-07
69584-672-90EA - Each69584-672e2ec0bee-1f0a-4175-bc2e-549e63945c4512022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69584-672PAROXETINE HYDROCHLORIDE TABLET, FILM COATED [OXFORD PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 5 package rows20240814_25182b68-8f7a-48e8-9788-6818b0984b29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSN25182b68-8f7a-48e8-9788-6818b0984b292
1738495PARoxetine HCl 20 MG Oral TabletPSN25182b68-8f7a-48e8-9788-6818b0984b292
1738503PARoxetine HCl 30 MG Oral TabletPSN25182b68-8f7a-48e8-9788-6818b0984b292
1738511PARoxetine HCl 40 MG Oral TabletPSN25182b68-8f7a-48e8-9788-6818b0984b292
1738483paroxetine hydrochloride 10 MG Oral TabletSCD25182b68-8f7a-48e8-9788-6818b0984b292
1738495paroxetine hydrochloride 20 MG Oral TabletSCD25182b68-8f7a-48e8-9788-6818b0984b292
1738503paroxetine hydrochloride 30 MG Oral TabletSCD25182b68-8f7a-48e8-9788-6818b0984b292
1738511paroxetine hydrochloride 40 MG Oral TabletSCD25182b68-8f7a-48e8-9788-6818b0984b292

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69584-672-036958406720330 TABLET, FILM COATED in 1 BOTTLE (69584-672-03) 2022-11-140000-00-00NoNoCurrent
69584-672-096958406720990 TABLET, FILM COATED in 1 BOTTLE (69584-672-09) 2022-11-140000-00-00NoNoCurrent
69584-672-1069584067210100 TABLET, FILM COATED in 1 BOTTLE (69584-672-10) 2022-11-140000-00-00NoNoCurrent
69584-672-5069584067250500 TABLET, FILM COATED in 1 BOTTLE (69584-672-50) 2022-11-140000-00-00NoNoCurrent
69584-672-90695840672901000 TABLET, FILM COATED in 1 BOTTLE (69584-672-90) 2022-11-140000-00-00NoNoCurrent