FDA.reportPublic FDA data

SERTRALINE

Product NDC
71610-769
11-digit product format
716100769
Labeler code
71610
Product ID
71610-769_13679124-92cd-bffa-e063-6394a90a219c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077397
Marketing category
ANDA
Marketing start
2012-08-20
Substance
SERTRALINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SERTRALINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SERTRALINE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUTI8907Y6X
Rxcui312938

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ac594ea-ad8b-47fd-9b52-bbd98301675eProduct name120220317
255fa467-900b-5557-4215-6823352d1150Product name220211028

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-769-15SERTRALINE15 in 1 BOTTLETABLET, FILM COATED152
71610-769-30SERTRALINE30 in 1 BOTTLETABLET, FILM COATED302
71610-769-45SERTRALINE45 in 1 BOTTLETABLET, FILM COATED452
71610-769-53SERTRALINE60 in 1 BOTTLETABLET, FILM COATED602
71610-769-60SERTRALINE90 in 1 BOTTLETABLET, FILM COATED902
71610-769-73SERTRALINE135 in 1 BOTTLETABLET, FILM COATED1352
71610-769-80SERTRALINE180 in 1 BOTTLETABLET, FILM COATED1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-769-15EA - Each71610-76919272015-7694-46e9-885a-e14395e4eb0f12024-03-12
71610-769-30EA - Each71610-769dac3c420-2bab-4c08-b402-b4ba7272c28e12024-05-16
71610-769-45EA - Each71610-7696b27f48a-6558-48c5-8cb6-f7dee1b06f0612024-03-12
71610-769-53EA - Each71610-76933cc8ec3-2bd2-451e-8316-d376881fb02f12024-03-12
71610-769-60EA - Each71610-76907fe6658-4f34-46bb-aa61-3d9cfc6979c612024-03-12
71610-769-73EA - Each71610-76956561a31-c855-4471-b8da-7de0745f397c12024-03-12
71610-769-80EA - Each71610-7695282356b-cd2c-40ed-b00a-d6c9183b9afc12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-769SERTRALINE (SERTRALINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, 7 package rows20240312_7be6a62e-0e85-47c8-8793-b41c51c2557f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN7be6a62e-0e85-47c8-8793-b41c51c2557f2
312938sertraline 100 MG Oral TabletSCD7be6a62e-0e85-47c8-8793-b41c51c2557f2
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY7be6a62e-0e85-47c8-8793-b41c51c2557f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-769-157161007691515 TABLET, FILM COATED in 1 BOTTLE (71610-769-15) 2024-01-17NoNoCurrent
71610-769-307161007693030 TABLET, FILM COATED in 1 BOTTLE (71610-769-30) 2024-03-07NoNoCurrent
71610-769-457161007694545 TABLET, FILM COATED in 1 BOTTLE (71610-769-45) 2024-01-17NoNoCurrent
71610-769-537161007695360 TABLET, FILM COATED in 1 BOTTLE (71610-769-53) 2024-01-17NoNoCurrent
71610-769-607161007696090 TABLET, FILM COATED in 1 BOTTLE (71610-769-60) 2024-01-17NoNoCurrent
71610-769-7371610076973135 TABLET, FILM COATED in 1 BOTTLE (71610-769-73) 2024-01-17NoNoCurrent
71610-769-8071610076980180 TABLET, FILM COATED in 1 BOTTLE (71610-769-80) 2024-01-17NoNoCurrent