FDA.reportPublic FDA data

Paroxetine

Product NDC
80425-0339
11-digit product format
804250339
Labeler code
80425
Product ID
80425-0339_2a9bf7d3-46dd-0dfa-e063-6394a90a76a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA077584
Marketing category
ANDA
Marketing start
2023-05-19
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Paroxetine
Listing expiration
2026-12-31

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
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
80425-0339-1Paroxetine30 in 1 BOTTLETABLET, FILM COATED302
80425-0339-2Paroxetine60 in 1 BOTTLETABLET, FILM COATED602
80425-0339-3Paroxetine90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0339-1EA - Each80425-03392c474175-6ae4-457a-b259-002e3a20778612023-07-06
80425-0339-2EA - Each80425-0339495ef767-6a45-49ce-8f74-e9c4aad50cfa12023-07-06
80425-0339-3EA - Each80425-0339de4d7351-04da-4a3d-a484-64c561c55b2d12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0339PAROXETINE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_fc11a056-7db5-1966-e053-6394a90aa59c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738495PARoxetine HCl 20 MG Oral TabletPSNfc11a056-7db5-1966-e053-6394a90aa59c2
1738495paroxetine hydrochloride 20 MG Oral TabletSCDfc11a056-7db5-1966-e053-6394a90aa59c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0339-18042503390130 TABLET, FILM COATED in 1 BOTTLE (80425-0339-1) 2023-05-19NoNoCurrent
80425-0339-28042503390260 TABLET, FILM COATED in 1 BOTTLE (80425-0339-2) 2023-05-19NoNoCurrent
80425-0339-38042503390390 TABLET, FILM COATED in 1 BOTTLE (80425-0339-3) 2023-05-19NoNoCurrent