FDA.reportPublic FDA data

Paroxetine

Product NDC
70518-0003
11-digit product format
705180003
Labeler code
70518
Product ID
70518-0003_4cc59709-1bb2-1f80-e063-6294a90a89a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077584
Marketing category
ANDA
Marketing start
2016-11-23
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
40 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 HEMIHYDRATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8
Rxcui1738511

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
70518-0003-0Paroxetine30 in 1 BLISTER PACKTABLET, FILM COATED3033
70518-0003-1Paroxetine90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9033
70518-0003-2Paroxetine30 in 1 BOXTABLET, FILM COATED3033
70518-0003-3Paroxetine1 in 1 POUCHTABLET, FILM COATED133
70518-0003-4Paroxetine30 in 1 BLISTER PACKTABLET, FILM COATED3033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-0003-0EA - Each70518-0003a0d06d4e-b22b-460a-9f95-796dd5f21a3512025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0003PAROXETINE TABLET, FILM COATED [REMEDYREPACK INC.]27Current NDC, Legacy NDC, 5 package rows20250509_bc0efd3b-c6b9-4ed0-b517-6e57e4700b7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738511PARoxetine HCl 40 MG Oral TabletPSNbc0efd3b-c6b9-4ed0-b517-6e57e4700b7b33
1738511paroxetine hydrochloride 40 MG Oral TabletSCDbc0efd3b-c6b9-4ed0-b517-6e57e4700b7b33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-0003-07051800030030 TABLET, FILM COATED in 1 BLISTER PACK (70518-0003-0) 2016-11-230000-00-00NoNoCurrent
70518-0003-17051800030190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0003-1) 2022-06-010000-00-00NoNoCurrent
70518-0003-27051800030230 in 1 BOXHistorical
70518-0003-3705180003031 in 1 POUCHHistorical
70518-0003-47051800030430 in 1 BLISTER PACKHistorical