FDA.reportPublic FDA data

PAROXETINE

Product NDC
61919-513
11-digit product format
619190513
Labeler code
61919
Product ID
61919-513_4c497215-c45a-4999-e063-6394a90a5cbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PAROXETINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA077584
Marketing category
ANDA
Marketing start
2016-02-29
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
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 HEMIHYDRATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-513-302022-10-12C16284748780-19d75b9d0-1ed3-f424-e053-dadaa90a57cePAROXETINE40 mg
61919-513-302020-01-31C16284748780-19d75b9d0-1ed3-f424-e053-dadaa90a57cePAROXETINE40 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-513-30PAROXETINE30 in 1 BOTTLETABLET, FILM COATED303
61919-513-90PAROXETINE90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-513-30EA - Each61919-51386415691-64de-48b7-bce3-503130fa382312016-03-04

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738511PARoxetine HCl 40 MG Oral TabletPSN2cfe30fc-9c46-4efd-e054-00144ff8d46c3
1738511paroxetine hydrochloride 40 MG Oral TabletSCD2cfe30fc-9c46-4efd-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
61919-513-306191905133030 in 1 BOTTLEHistorical
61919-513-906191905139090 TABLET, FILM COATED in 1 BOTTLE (61919-513-90) 2016-02-29NoNoHistorical