FDA.reportPublic FDA data

Paroxetine

Product NDC
70518-2387
11-digit product format
705182387
Labeler code
70518
Product ID
70518-2387_4a15aba9-9e60-26ca-e063-6294a90abf2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride hemihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA203854
Marketing category
ANDA
Marketing start
2019-10-24
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
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 HEMIHYDRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8
Rxcui1738495

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
70518-2387-0Paroxetine30 in 1 BOXTABLET, FILM COATED3011
70518-2387-1Paroxetine1 in 1 POUCHTABLET, FILM COATED111
70518-2387-2Paroxetine30 in 1 BOXTABLET, FILM COATED3011
70518-2387-3Paroxetine1 in 1 POUCHTABLET, FILM COATED111
70518-2387-4Paroxetine30 in 1 BLISTER PACKTABLET, FILM COATED3011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2387PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 5 package rows20240507_4cb9dc05-adb8-4c88-ad40-af8c0df1cafd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738495PARoxetine HCl 20 MG Oral TabletPSN4cb9dc05-adb8-4c88-ad40-af8c0df1cafd11
1738495paroxetine hydrochloride 20 MG Oral TabletSCD4cb9dc05-adb8-4c88-ad40-af8c0df1cafd11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2387-07051823870030 POUCH in 1 BOX, UNIT-DOSE (70518-2387-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-2387-1) 30 pouch2019-10-240000-00-00NoNoCurrent
70518-2387-1705182387011 in 1 POUCHHistorical
70518-2387-27051823870230 POUCH in 1 BOX (70518-2387-2) / 1 TABLET, FILM COATED in 1 POUCH (70518-2387-3) 30 pouch2021-08-050000-00-00NoNoCurrent
70518-2387-3705182387031 in 1 POUCHHistorical
70518-2387-47051823870430 in 1 BLISTER PACKHistorical