Sertraline Hydrochloride

Product NDC
50090-3217
11-digit product format
500903217
Labeler code
50090
Product ID
50090-3217_9537e3a5-567d-4e40-a536-ab3aaf9bfcf6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077397
Marketing category
ANDA
Marketing start
2016-07-21
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3217-0Sertraline Hydrochloride33 in 1 BOX, UNIT-DOSETABLET3316
50090-3217-0Sertraline Hydrochloride1 in 1 BLISTER PACKTABLET116

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3217SERTRALINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]16Legacy NDC, 2 package rows20180918_7a16bb3b-8512-4ded-b37c-81c7b8773b96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN7a16bb3b-8512-4ded-b37c-81c7b8773b9616
312938sertraline 100 MG Oral TabletSCD7a16bb3b-8512-4ded-b37c-81c7b8773b9616
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY7a16bb3b-8512-4ded-b37c-81c7b8773b9616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-3217-05009032170033 in 1 BOX, UNIT-DOSEHistorical