FDA.reportPublic FDA data

Paroxetine

Product NDC
65841-097
11-digit product format
658410097
Labeler code
65841
Product ID
65841-097_ef5c1ef5-2884-4395-a65a-92591c986150
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA077584
Marketing category
ANDA
Marketing start
2007-04-13
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

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 Identifiers#

Field, Values table
FieldValues
Unii3I3T11UD2S
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
65841-097-01Paroxetine100 in 1 BOTTLETABLET, FILM COATED10013
65841-097-05Paroxetine500 in 1 BOTTLETABLET, FILM COATED50013
65841-097-06Paroxetine30 in 1 BOTTLETABLET, FILM COATED3013
65841-097-10Paroxetine1000 in 1 BOTTLETABLET, FILM COATED100013
65841-097-16Paroxetine90 in 1 BOTTLETABLET, FILM COATED9013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-097PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]13Current NDC, Legacy NDC, 5 package rows20241207_6d5fcdb2-4d84-4b20-87e3-58a43e567500.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSN6d5fcdb2-4d84-4b20-87e3-58a43e56750013
1738495PARoxetine HCl 20 MG Oral TabletPSN6d5fcdb2-4d84-4b20-87e3-58a43e56750013
1738503PARoxetine HCl 30 MG Oral TabletPSN6d5fcdb2-4d84-4b20-87e3-58a43e56750013
1738511PARoxetine HCl 40 MG Oral TabletPSN6d5fcdb2-4d84-4b20-87e3-58a43e56750013
1738483paroxetine hydrochloride 10 MG Oral TabletSCD6d5fcdb2-4d84-4b20-87e3-58a43e56750013
1738495paroxetine hydrochloride 20 MG Oral TabletSCD6d5fcdb2-4d84-4b20-87e3-58a43e56750013
1738503paroxetine hydrochloride 30 MG Oral TabletSCD6d5fcdb2-4d84-4b20-87e3-58a43e56750013
1738511paroxetine hydrochloride 40 MG Oral TabletSCD6d5fcdb2-4d84-4b20-87e3-58a43e56750013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65841-097-0165841009701100 TABLET, FILM COATED in 1 BOTTLE (65841-097-01) 2007-04-130000-00-00NoNoCurrent
65841-097-0565841009705500 TABLET, FILM COATED in 1 BOTTLE (65841-097-05) 2007-04-130000-00-00NoNoCurrent
65841-097-066584100970630 TABLET, FILM COATED in 1 BOTTLE (65841-097-06) 2007-04-130000-00-00NoNoCurrent
65841-097-10658410097101000 TABLET, FILM COATED in 1 BOTTLE (65841-097-10) 2007-04-130000-00-00NoNoCurrent
65841-097-166584100971690 TABLET, FILM COATED in 1 BOTTLE (65841-097-16) 2007-04-130000-00-00NoNoCurrent