FDA.reportPublic FDA data

SERTRALINE HYDROCHLORIDE

Product NDC
71093-130
11-digit product format
710930130
Labeler code
71093
Product ID
71093-130_701d9091-1809-4afe-94af-f36fd04c174a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SERTRALINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
ACI Healthcare USA, Inc.
Application
ANDA076881
Marketing category
ANDA
Marketing start
2007-02-06
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ac594ea-ad8b-47fd-9b52-bbd98301675eProduct name120220317
255fa467-900b-5557-4215-6823352d1150Product name220211028

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71093-130-01SERTRALINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET306
71093-130-03SERTRALINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET906
71093-130-05SERTRALINE HYDROCHLORIDE500 in 1 BOTTLE, PLASTICTABLET5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71093-130-01EA - Each71093-13086f8c074-8f18-4883-80b0-c85959a7376d12021-08-05
71093-130-03EA - Each71093-1304558bc96-b145-47c5-87e7-2f8761e9c4f812021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71093-130SERTRALINE HYDROCHLORIDE TABLET [ACI HEALTHCARE USA, INC.]6Legacy NDC, 3 package rows20230410_1f99e897-1b70-40b0-8c19-71d0bba19422.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN1f99e897-1b70-40b0-8c19-71d0bba194226
312940sertraline HCl 25 MG Oral TabletPSN1f99e897-1b70-40b0-8c19-71d0bba194226
312941sertraline HCl 50 MG Oral TabletPSN1f99e897-1b70-40b0-8c19-71d0bba194226
312938sertraline 100 MG Oral TabletSCD1f99e897-1b70-40b0-8c19-71d0bba194226
312940sertraline 25 MG Oral TabletSCD1f99e897-1b70-40b0-8c19-71d0bba194226
312941sertraline 50 MG Oral TabletSCD1f99e897-1b70-40b0-8c19-71d0bba194226
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY1f99e897-1b70-40b0-8c19-71d0bba194226
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY1f99e897-1b70-40b0-8c19-71d0bba194226
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY1f99e897-1b70-40b0-8c19-71d0bba194226

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71093-130-017109301300130 TABLET in 1 BOTTLE, PLASTIC (71093-130-01) 30 tablet2018-08-200000-00-00NoNoCurrent
71093-130-037109301300390 TABLET in 1 BOTTLE, PLASTIC (71093-130-03) 90 tablet2018-08-200000-00-00NoNoCurrent
71093-130-0571093013005500 TABLET in 1 BOTTLE, PLASTIC (71093-130-05) 500 tablet2018-08-200000-00-00NoNoCurrent