FDA.reportPublic FDA data

PAROXETINE

Product NDC
70518-2871
11-digit product format
705182871
Labeler code
70518
Product ID
70518-2871_4b051cf4-2456-e66e-e063-6294a90af78e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075356
Marketing category
ANDA
Marketing start
2020-09-08
Substance
PAROXETINE HYDROCHLORIDE ANHYDROUS
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 ANHYDROUS20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3I3T11UD2S
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2871-02022-02-08C16284748780-1d6a99b39-7b81-a426-e053-dadaa90af4c2These 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
70518-2871-02022-01-28C16284748780-1d6a99b39-7b81-a426-e053-dadaa90af4c2These 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
70518-2871-0PAROXETINE100 in 1 BOXTABLET, FILM COATED10015
70518-2871-1PAROXETINE1 in 1 POUCHTABLET, FILM COATED115

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2871PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 2 package rows20250406_98d4f767-06e3-4d9b-b1ad-4b31f7e36130.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738495PARoxetine HCl 20 MG Oral TabletPSN98d4f767-06e3-4d9b-b1ad-4b31f7e3613015
1738495paroxetine hydrochloride 20 MG Oral TabletSCD98d4f767-06e3-4d9b-b1ad-4b31f7e3613015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2871-070518287100100 POUCH in 1 BOX (70518-2871-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-2871-1) 100 pouch2020-09-080000-00-00NoNoCurrent
70518-2871-1705182871011 in 1 POUCHHistorical