FDA.reportPublic FDA data

paroxetine hydrochloride

Product NDC
69584-673
11-digit product format
695840673
Labeler code
69584
Product ID
69584-673_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
30 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8
Rxcui1738483, 1738495, 1738503, 1738511

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
69584-673-03paroxetine hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
69584-673-09paroxetine hydrochloride90 in 1 BOTTLETABLET, FILM COATED902
69584-673-10paroxetine hydrochloride100 in 1 BOTTLETABLET, FILM COATED1002
69584-673-50paroxetine hydrochloride500 in 1 BOTTLETABLET, FILM COATED5002
69584-673-90paroxetine hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69584-673-03EA - Each69584-67358146b26-aadf-4d21-887c-dfed18320a8212022-12-07
69584-673-09EA - Each69584-6733b8c2684-2051-4f55-968c-b9af7dc2166d12022-12-07
69584-673-50EA - Each69584-6733cad3f0b-34f6-4d8b-93a9-5bb8d3108e0e12022-12-07
69584-673-90EA - Each69584-673e8879b15-444e-41a2-8799-b000f95be15812022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69584-673PAROXETINE 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
1738503PARoxetine HCl 30 MG Oral TabletPSNc3c204df-6b7d-42fb-8794-4f38064ed963102
1738503paroxetine hydrochloride 30 MG Oral TabletSCDc3c204df-6b7d-42fb-8794-4f38064ed963102
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
69584-673-036958406730330 TABLET, FILM COATED in 1 BOTTLE (69584-673-03) 2022-11-140000-00-00NoNoCurrent
69584-673-096958406730990 TABLET, FILM COATED in 1 BOTTLE (69584-673-09) 2022-11-140000-00-00NoNoCurrent
69584-673-1069584067310100 TABLET, FILM COATED in 1 BOTTLE (69584-673-10) 2022-11-140000-00-00NoNoCurrent
69584-673-5069584067350500 TABLET, FILM COATED in 1 BOTTLE (69584-673-50) 2022-11-140000-00-00NoNoCurrent
69584-673-90695840673901000 TABLET, FILM COATED in 1 BOTTLE (69584-673-90) 2022-11-140000-00-00NoNoCurrent