SERTRALINE HYDROCHLORIDE

Product NDC
59762-5160
11-digit product format
597625160
Labeler code
59762
Product ID
59762-5160_e73de26b-297b-4a29-b4d2-8d59e6c70320
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sertraline hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Greenstone LLC
Application
NDA019839
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-08-12
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-5160-1EA - Each59762-516095327935-a606-442b-9983-e85ddda15b7812019-09-05
59762-5160-2EA - Each59762-51608406ec04-31bc-479d-a22a-2b9814c9317612019-09-05
59762-5160-3EA - Each59762-51606e0fad91-ed21-4ed2-81f9-0a83e98fc40912019-09-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSNccb264a4-5d50-4317-a67e-ba6daa2b82971
312938sertraline 100 MG Oral TabletSCDccb264a4-5d50-4317-a67e-ba6daa2b82971
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYccb264a4-5d50-4317-a67e-ba6daa2b82971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-5160-15976251600130 TABLET, FILM COATED in 1 BOTTLE (59762-5160-1) 2019-08-120000-00-00NoNoCurrent
59762-5160-259762516002100 TABLET, FILM COATED in 1 BOTTLE (59762-5160-2) 2019-08-120000-00-00NoNoCurrent
59762-5160-359762516003500 TABLET, FILM COATED in 1 BOTTLE (59762-5160-3) 2019-08-120000-00-00NoNoCurrent