FDA.reportPublic FDA data

Paroxetine

Product NDC
70518-3518
11-digit product format
705183518
Labeler code
70518
Product ID
70518-3518_4f983394-d7ad-5db3-e063-6394a90a271a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077584
Marketing category
ANDA
Marketing start
2022-09-13
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
70518-3518-0Paroxetine100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1008
70518-3518-1Paroxetine30 in 1 BLISTER PACKTABLET, FILM COATED308
70518-3518-2Paroxetine100 in 1 BOXTABLET, FILM COATED1008
70518-3518-3Paroxetine1 in 1 POUCHTABLET, FILM COATED18
70518-3518-4Paroxetine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED308
70518-3518-6Paroxetine45 in 1 BOTTLE, PLASTICTABLET, FILM COATED458

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3518PAROXETINE TABLET, FILM COATED [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 6 package rows20250523_05ec70fd-4c65-495f-ba12-e8433a10b655.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738495PARoxetine HCl 20 MG Oral TabletPSN05ec70fd-4c65-495f-ba12-e8433a10b6558
1738495paroxetine hydrochloride 20 MG Oral TabletSCD05ec70fd-4c65-495f-ba12-e8433a10b6558

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3518-070518351800100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3518-0) 2022-09-130000-00-00NoNoCurrent
70518-3518-17051835180130 TABLET, FILM COATED in 1 BLISTER PACK (70518-3518-1) 2022-09-290000-00-00NoNoCurrent
70518-3518-270518351802100 POUCH in 1 BOX (70518-3518-2) / 1 TABLET, FILM COATED in 1 POUCH (70518-3518-3) 100 pouch2025-01-31NoNoCurrent
70518-3518-3705183518031 in 1 POUCHHistorical
70518-3518-47051835180430 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3518-4) 2025-06-18NoNoCurrent
70518-3518-67051835180645 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3518-6) 2026-04-16NoNoCurrent