PAROXETINE

Product NDC
71610-348
11-digit product format
716100348
Labeler code
71610
Product ID
71610-348_d034f130-114a-4c90-a745-12f5a053b60a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075356
Marketing category
ANDA
Marketing start
2003-07-30
Marketing end
0000-00-00
Substance
PAROXETINE HYDROCHLORIDE ANHYDROUS
Active strength
10 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
71610-348-602023-01-30C16284748780-1f386c64a-2801-0266-e053-dadaa90a7c1aPAROXETINE TABLETS, USP 10 mg, 20 mg, 30 mg and 40 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-348-60PAROXETINE90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-348-60EA - Each71610-348fd16cea3-2a9d-4418-afc9-a35d0de40fed12019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-348PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 1 package rows20191120_4e2a2cd6-522c-453d-aaa7-4ad9abcaeef1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSN4e2a2cd6-522c-453d-aaa7-4ad9abcaeef11
1738483paroxetine hydrochloride 10 MG Oral TabletSCD4e2a2cd6-522c-453d-aaa7-4ad9abcaeef11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-348-607161003486090 TABLET, FILM COATED in 1 BOTTLE (71610-348-60) 2019-10-080000-00-00NoNoCurrent