FDA.reportPublic FDA data

paroxetine hydrochloride

Product NDC
69986-011
11-digit product format
699860011
Labeler code
69986
Product ID
69986-011_301e1265-07fa-4770-998a-eded59e3f204
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Sinotherapeutics Inc.
Application
ANDA213612
Marketing category
ANDA
Marketing start
2022-02-09
Marketing end
0000-00-00
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
13 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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
69986-011-012025-01-30C16284748780-12cef2736-a071-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use PAROXETINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PAROXETINE EXTENDED-RELEASE TABLETS. PAROXETINE extended-release tablets, for oral use Initial U.S. Approval: 1992
69986-011-182025-01-30C16284748780-12cef2736-a071-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use PAROXETINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PAROXETINE EXTENDED-RELEASE TABLETS. PAROXETINE extended-release tablets, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69986-011-01paroxetine hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE309
69986-011-18paroxetine hydrochloride30 in 1 CARTONTABLET, FILM COATED, EXTENDED RE309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69986-011PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SINOTHERAPEUTICS INC.]9Legacy NDC, 2 package rows20231222_1ecde740-d3f2-4937-b7a0-8ceccd48f923.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738803PARoxetine HCl 12.5 MG 24HR Extended Release Oral TabletPSN1ecde740-d3f2-4937-b7a0-8ceccd48f9239
1738805PARoxetine HCl 25 MG 24HR Extended Release Oral TabletPSN1ecde740-d3f2-4937-b7a0-8ceccd48f9239
1738807PARoxetine HCl 37.5 MG 24HR Extended Release Oral TabletPSN1ecde740-d3f2-4937-b7a0-8ceccd48f9239
173880324 HR paroxetine hydrochloride 12.5 MG Extended Release Oral TabletSCD1ecde740-d3f2-4937-b7a0-8ceccd48f9239
173880524 HR paroxetine hydrochloride 25 MG Extended Release Oral TabletSCD1ecde740-d3f2-4937-b7a0-8ceccd48f9239
173880724 HR paroxetine hydrochloride 37.5 MG Extended Release Oral TabletSCD1ecde740-d3f2-4937-b7a0-8ceccd48f9239
1738803paroxetine hydrochloride 12.5 MG 24 HR Extended Release Oral TabletSY1ecde740-d3f2-4937-b7a0-8ceccd48f9239
1738805paroxetine hydrochloride 25 MG 24 HR Extended Release Oral TabletSY1ecde740-d3f2-4937-b7a0-8ceccd48f9239
1738807paroxetine hydrochloride 37.5 MG 24 HR Extended Release Oral TabletSY1ecde740-d3f2-4937-b7a0-8ceccd48f9239

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69986-011-016998600110130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69986-011-01) 2022-02-090000-00-00NoNoCurrent
69986-011-186998600111830 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (69986-011-18) 2022-02-090000-00-00NoNoCurrent