FDA.reportPublic FDA data

Paroxetine

Product NDC
70518-3430
11-digit product format
705183430
Labeler code
70518
Product ID
70518-3430_4f08399b-1e85-9ae0-e063-6294a90aec75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077584
Marketing category
ANDA
Marketing start
2022-06-02
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
10 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Paroxetine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8
Rxcui1738483

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
70518-3430-0Paroxetine90 in 1 BOTTLE, PLASTICTABLET, FILM COATED908
70518-3430-1Paroxetine30 in 1 BLISTER PACKTABLET, FILM COATED308
70518-3430-2Paroxetine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3430PAROXETINE TABLET, FILM COATED [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 3 package rows20250423_c002508e-f96c-413b-b232-5d55fceeffe0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSNc002508e-f96c-413b-b232-5d55fceeffe08
1738483paroxetine hydrochloride 10 MG Oral TabletSCDc002508e-f96c-413b-b232-5d55fceeffe08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3430-07051834300090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3430-0) 2022-06-020000-00-00NoNoCurrent
70518-3430-17051834300130 TABLET, FILM COATED in 1 BLISTER PACK (70518-3430-1) 2022-06-240000-00-00NoNoCurrent
70518-3430-27051834300230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3430-2) 2025-08-01NoNoHistorical