FDA.reportPublic FDA data

SERTRALINE

Product NDC
71610-818
11-digit product format
716100818
Labeler code
71610
Product ID
71610-818_3a7784f8-edc2-8cb2-e063-6294a90a8cdc
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
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
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 HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUTI8907Y6X
Rxcui312941

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
71610-818-15SERTRALINE15 in 1 BOTTLETABLET, FILM COATED154
71610-818-30SERTRALINE30 in 1 BOTTLETABLET, FILM COATED304
71610-818-45SERTRALINE45 in 1 BOTTLETABLET, FILM COATED454
71610-818-60SERTRALINE90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-818-15EA - Each71610-818b7b7218c-2aad-4770-b1c1-bb4875c0977d12024-06-10
71610-818-30EA - Each71610-818407f2e1f-6a3f-45fe-9499-6fb5828d901912025-08-11
71610-818-45EA - Each71610-818407d40fb-92ec-4913-8d8f-8aba27b71f7012024-05-16
71610-818-60EA - Each71610-818ec046825-7023-4740-96ff-0b04435e82b412024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-818SERTRALINE (SERTRALINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]3Current NDC, 4 package rows20240625_1548faf9-8625-f871-e063-6394a90a931f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312941sertraline HCl 50 MG Oral TabletPSN1548faf9-8625-f871-e063-6394a90a931f4
312941sertraline 50 MG Oral TabletSCD1548faf9-8625-f871-e063-6394a90a931f4
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY1548faf9-8625-f871-e063-6394a90a931f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-818-157161008181515 TABLET, FILM COATED in 1 BOTTLE (71610-818-15) 2024-04-12NoNoHistorical
71610-818-307161008183030 TABLET, FILM COATED in 1 BOTTLE (71610-818-30) 2025-07-17NoNoHistorical
71610-818-457161008184545 TABLET, FILM COATED in 1 BOTTLE (71610-818-45) 2024-04-04NoNoHistorical
71610-818-607161008186090 TABLET, FILM COATED in 1 BOTTLE (71610-818-60) 2024-06-20NoNoHistorical