Sertraline Hydrochloride

Product NDC
50436-6305
11-digit product format
504366305
Labeler code
50436
Product ID
50436-6305_fc2f7db2-1614-4e5f-a32c-0f0ca9a9749d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA077397
Marketing category
ANDA
Marketing start
2007-10-18
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-6305-12020-01-31C16284748780-19d75b9d0-b7be-f424-e053-dadaa90a57ceSertraline Hydrochloride Tablets 25 mg, 50 mg and 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-6305-1Sertraline Hydrochloride30 in 1 BOTTLETABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-6305SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET [UNIT DOSE SERVICES]5Legacy NDC, 1 package rows20170726_aa1026ed-fcaa-4442-a3f8-b5e0b600b51f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSNaa1026ed-fcaa-4442-a3f8-b5e0b600b51f5
312938sertraline 100 MG Oral TabletSCDaa1026ed-fcaa-4442-a3f8-b5e0b600b51f5
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYaa1026ed-fcaa-4442-a3f8-b5e0b600b51f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-6305-15043663050130 in 1 BOTTLEHistorical