FDA.reportPublic FDA data

Paroxetine

Product NDC
70518-2574
11-digit product format
705182574
Labeler code
70518
Product ID
70518-2574_4a6883b0-36a2-14fa-e063-6294a90a281c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078406
Marketing category
ANDA
Marketing start
2020-02-10
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2574-02023-03-10C16284748780-1f386c649-b6bc-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE tablets, for oral use Initial U.S. Approval: 1992
70518-2574-12023-03-10C16284748780-1f386c649-b6bc-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE tablets, for oral use Initial U.S. Approval: 1992
70518-2574-02023-01-30C16284748780-1f386c649-b6bc-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE tablets, for oral use Initial U.S. Approval: 1992
70518-2574-12023-01-30C16284748780-1f386c649-b6bc-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE tablets, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2574-0Paroxetine90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9011
70518-2574-1Paroxetine30 in 1 BOXTABLET, FILM COATED3011
70518-2574-2Paroxetine1 in 1 POUCHTABLET, FILM COATED111
70518-2574-3Paroxetine30 in 1 BLISTER PACKTABLET, FILM COATED3011
70518-2574-4Paroxetine90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2574PAROXETINE TABLET, FILM COATED [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 5 package rows20250321_f52ca1fc-fbf7-4b2b-9e74-975c310b8ce6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSNf52ca1fc-fbf7-4b2b-9e74-975c310b8ce611
1738483paroxetine hydrochloride 10 MG Oral TabletSCDf52ca1fc-fbf7-4b2b-9e74-975c310b8ce611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2574-07051825740090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2574-0) 2020-02-100000-00-00NoNoCurrent
70518-2574-17051825740130 POUCH in 1 BOX (70518-2574-1) > 1 TABLET, FILM COATED in 1 POUCH (70518-2574-2) 30 pouch2020-09-020000-00-00NoNoCurrent
70518-2574-2705182574021 in 1 POUCHHistorical
70518-2574-37051825740330 in 1 BLISTER PACKHistorical
70518-2574-47051825740490 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2574-4) 2024-10-09NoNoHistorical