FDA.reportPublic FDA data

SERTRALINE HYDROCHLORIDE

Product NDC
50090-3947
11-digit product format
500903947
Labeler code
50090
Product ID
50090-3947_01420c85-1447-4970-b0a5-b0e4d9f2c8df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SERTRALINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202825
Marketing category
ANDA
Marketing start
2017-02-09
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
25 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
4ac594ea-ad8b-47fd-9b52-bbd98301675eProduct name120220317
255fa467-900b-5557-4215-6823352d1150Product name220211028

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3947-02023-01-30C16284748780-1f386c64a-0481-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
50090-3947-12023-01-30C16284748780-1f386c64a-0481-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3947-0SERTRALINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED308
50090-3947-1SERTRALINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3947-0EA - Each50090-394781dd570c-9a7e-43b7-ac54-de6ddbb4d32d12021-12-08
50090-3947-1EA - Each50090-3947e55d5a44-df32-4012-85e0-bc8a6bcea94612021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3947SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]8Legacy NDC, 2 package rows20210617_3423456b-6a0f-4406-b910-a3dc9d3ffadd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312940sertraline HCl 25 MG Oral TabletPSN3423456b-6a0f-4406-b910-a3dc9d3ffadd8
312940sertraline 25 MG Oral TabletSCD3423456b-6a0f-4406-b910-a3dc9d3ffadd8
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY3423456b-6a0f-4406-b910-a3dc9d3ffadd8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3947-05009039470030 TABLET, FILM COATED in 1 BOTTLE (50090-3947-0) 2018-12-100000-00-00NoNoCurrent
50090-3947-15009039470190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3947-1) 2017-02-090000-00-00NoNoCurrent