FDA.reportPublic FDA data

Paroxetine

Product NDC
69117-0025
11-digit product format
691170025
Labeler code
69117
Product ID
69117-0025_472863af-ee04-24a6-e063-6394a90a9e20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Yiling Pharmaceutical, Inc.
Application
ANDA211248
Marketing category
ANDA
Marketing start
2021-11-02
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE20 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
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
69117-0025-1Paroxetine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED308
69117-0025-2Paroxetine90 in 1 BOTTLE, PLASTICTABLET, FILM COATED908
69117-0025-3Paroxetine100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1008
69117-0025-4Paroxetine500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5008
69117-0025-5Paroxetine1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69117-0025PAROXETINE TABLET, FILM COATED [YILING PHARMACEUTICAL, INC.]7Current NDC, Legacy NDC, 5 package rows20250101_4abd94c5-5ad5-4a43-9c51-a93ea1c1f3bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSN4abd94c5-5ad5-4a43-9c51-a93ea1c1f3bc8
1738495PARoxetine HCl 20 MG Oral TabletPSN4abd94c5-5ad5-4a43-9c51-a93ea1c1f3bc8
1738503PARoxetine HCl 30 MG Oral TabletPSN4abd94c5-5ad5-4a43-9c51-a93ea1c1f3bc8
1738511PARoxetine HCl 40 MG Oral TabletPSN4abd94c5-5ad5-4a43-9c51-a93ea1c1f3bc8
1738483paroxetine hydrochloride 10 MG Oral TabletSCD4abd94c5-5ad5-4a43-9c51-a93ea1c1f3bc8
1738495paroxetine hydrochloride 20 MG Oral TabletSCD4abd94c5-5ad5-4a43-9c51-a93ea1c1f3bc8
1738503paroxetine hydrochloride 30 MG Oral TabletSCD4abd94c5-5ad5-4a43-9c51-a93ea1c1f3bc8
1738511paroxetine hydrochloride 40 MG Oral TabletSCD4abd94c5-5ad5-4a43-9c51-a93ea1c1f3bc8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69117-0025-16911700250130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0025-1) 2021-11-020000-00-00NoNoCurrent
69117-0025-26911700250290 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0025-2) 2021-11-020000-00-00NoNoCurrent
69117-0025-369117002503100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0025-3) 2021-11-020000-00-00NoNoCurrent
69117-0025-469117002504500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0025-4) 2021-11-020000-00-00NoNoCurrent
69117-0025-5691170025051000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0025-5) 2021-11-020000-00-00NoNoCurrent