FDA.reportPublic FDA data

Paroxetine

Product NDC
70518-2465
11-digit product format
705182465
Labeler code
70518
Product ID
70518-2465_4a29ce0a-3c5e-53d2-e063-6394a90aedcc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077584
Marketing category
ANDA
Marketing start
2019-12-14
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
30 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 HEMIHYDRATE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8
Rxcui1738503

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
70518-2465-0Paroxetine30 in 1 BLISTER PACKTABLET, FILM COATED3015
70518-2465-1Paroxetine90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9015
70518-2465-2Paroxetine90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9015
70518-2465-3Paroxetine30 in 1 BLISTER PACKTABLET, FILM COATED3015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2465PAROXETINE TABLET, FILM COATED [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 4 package rows20250508_679e4b9b-0f7b-450a-aca7-1b448cccbeed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738503PARoxetine HCl 30 MG Oral TabletPSN679e4b9b-0f7b-450a-aca7-1b448cccbeed15
1738503paroxetine hydrochloride 30 MG Oral TabletSCD679e4b9b-0f7b-450a-aca7-1b448cccbeed15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2465-07051824650030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2465-0) 2019-12-140000-00-00NoNoCurrent
70518-2465-17051824650190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2465-1) 2021-09-240000-00-00NoNoCurrent
70518-2465-27051824650290 in 1 BOTTLE, PLASTICHistorical
70518-2465-37051824650330 in 1 BLISTER PACKHistorical