FDA.reportPublic FDA data

PAROXETINE

Product NDC
70518-0993
11-digit product format
705180993
Labeler code
70518
Product ID
70518-0993_4849915c-b1ac-5f0c-e063-6394a90a16e4
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
2018-01-29
Substance
PAROXETINE HYDROCHLORIDE ANHYDROUS
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 ANHYDROUS40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3I3T11UD2S
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
70518-0993-0PAROXETINE30 in 1 BLISTER PACKTABLET, FILM COATED3017
70518-0993-1PAROXETINE100 in 1 BOXTABLET, FILM COATED10017
70518-0993-2PAROXETINE1 in 1 POUCHTABLET, FILM COATED117

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0993PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC.]14Current NDC, Legacy NDC, 3 package rows20250424_beb87e2e-0a8f-43b6-b148-57f0b7191548.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738511PARoxetine HCl 40 MG Oral TabletPSNbeb87e2e-0a8f-43b6-b148-57f0b719154817
1738511paroxetine hydrochloride 40 MG Oral TabletSCDbeb87e2e-0a8f-43b6-b148-57f0b719154817

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0993-07051809930030 in 1 BLISTER PACKHistorical
70518-0993-170518099301100 POUCH in 1 BOX (70518-0993-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-0993-2) 100 pouch2020-09-080000-00-00NoNoCurrent
70518-0993-2705180993021 in 1 POUCHHistorical