FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
61919-345
11-digit product format
619190345
Labeler code
61919
Product ID
61919-345_f2133373-5541-7bb7-e053-2a95a90ac3fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct Rx
Application
ANDA202825
Marketing category
ANDA
Marketing start
2017-10-11
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
2024-12-31
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
61919-345-302025-01-30C16284748780-12cef2736-6ec3-d83d-e063-dadaa90ab31fSertraline hcl 50mg
61919-345-902023-01-30C16284748780-1f386c64a-439a-0266-e053-dadaa90a7c1aSertraline hcl 50mg
61919-345-602020-01-31C16284748780-19d75b9cf-e63c-f424-e053-dadaa90a57ceSERTRALINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-345-30Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED303
61919-345-90Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED903
61919-345-60SERTRALINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-345-30EA - Each61919-345c5b7d50e-1ed2-4d58-a102-b952a66e5cf612019-03-12
61919-345-60EA - Each61919-3453b59411a-c498-4db4-a886-6d664731d35d12019-08-06
61919-345-90EA - Each61919-3452f7da176-ab1e-4e76-8af3-68ca4ab20b9712019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-345SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]3Legacy NDC, 1 package rows20230113_5b453bcb-b110-4993-e053-2991aa0a8779.zip
61919-345SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT_RX]3Legacy NDC, 1 package rows20210108_8fefed07-ea11-0482-e053-2995a90a87d4.zip
61919-345SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]1Legacy NDC, 1 package rows20180314_675fea8e-6eb4-86ce-e053-2991aa0a0a88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312941sertraline HCl 50 MG Oral TabletPSN5b453bcb-b110-4993-e053-2991aa0a87793
312941sertraline HCl 50 MG Oral TabletPSN8fefed07-ea11-0482-e053-2995a90a87d43
312941sertraline 50 MG Oral TabletSCD5b453bcb-b110-4993-e053-2991aa0a87793
312941sertraline 50 MG Oral TabletSCD8fefed07-ea11-0482-e053-2995a90a87d43
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY5b453bcb-b110-4993-e053-2991aa0a87793
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY8fefed07-ea11-0482-e053-2995a90a87d43
312941sertraline HCl 50 MG Oral TabletPSN675fea8e-6eb4-86ce-e053-2991aa0a0a881
312941sertraline 50 MG Oral TabletSCD675fea8e-6eb4-86ce-e053-2991aa0a0a881
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY675fea8e-6eb4-86ce-e053-2991aa0a0a881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-345-306191903453030 TABLET, FILM COATED in 1 BOTTLE (61919-345-30) 2017-10-110000-00-00NoNoCurrent
61919-345-606191903456060 in 1 BOTTLEHistorical
61919-345-906191903459090 TABLET, FILM COATED in 1 BOTTLE (61919-345-90) 2019-08-120000-00-00NoNoCurrent