FDA.reportPublic FDA data

SERTRALINE HYDROCHLORIDE

Product NDC
71610-651
11-digit product format
716100651
Labeler code
71610
Product ID
71610-651_a189f92d-a14a-45be-8f55-4b81fe2dce92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SERTRALINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA202825
Marketing category
ANDA
Marketing start
2017-02-09
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 HYDROCHLORIDE
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
71610-651-15SERTRALINE HYDROCHLORIDE15 in 1 BOTTLETABLET, FILM COATED152
71610-651-30SERTRALINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED302
71610-651-45SERTRALINE HYDROCHLORIDE45 in 1 BOTTLETABLET, FILM COATED452
71610-651-53SERTRALINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED602
71610-651-60SERTRALINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED902
71610-651-73SERTRALINE HYDROCHLORIDE135 in 1 BOTTLETABLET, FILM COATED1352
71610-651-80SERTRALINE HYDROCHLORIDE180 in 1 BOTTLETABLET, FILM COATED1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-651-15EA - Each71610-651dca4e96b-51d3-4715-ab94-5551685ca36212022-07-06
71610-651-30EA - Each71610-651b96c277e-26c1-4c4a-9afa-1e0c7b9bc00012022-07-06
71610-651-45EA - Each71610-65121ce297a-b2e9-4025-93e0-f81a56adb4d712022-07-06
71610-651-53EA - Each71610-651b10775b5-0502-4740-970c-706680ec251112022-07-06
71610-651-60EA - Each71610-651f4ae838f-5f75-4704-bf79-8f7589de8b1712022-07-06
71610-651-73EA - Each71610-65140497e81-9b1f-401e-88f7-a60d043f24b212022-07-06
71610-651-80EA - Each71610-6516c2682f2-3773-4eb8-8929-38263dda2d1f12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-651SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 7 package rows20220626_68c94fb4-3018-44af-b982-2b4b6d461e6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN68c94fb4-3018-44af-b982-2b4b6d461e6f2
312938sertraline 100 MG Oral TabletSCD68c94fb4-3018-44af-b982-2b4b6d461e6f2
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY68c94fb4-3018-44af-b982-2b4b6d461e6f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-651-157161006511515 TABLET, FILM COATED in 1 BOTTLE (71610-651-15) 2022-06-230000-00-00NoNoCurrent
71610-651-307161006513030 TABLET, FILM COATED in 1 BOTTLE (71610-651-30) 2022-06-200000-00-00NoNoCurrent
71610-651-457161006514545 TABLET, FILM COATED in 1 BOTTLE (71610-651-45) 2022-06-200000-00-00NoNoCurrent
71610-651-537161006515360 TABLET, FILM COATED in 1 BOTTLE (71610-651-53) 2022-06-200000-00-00NoNoCurrent
71610-651-607161006516090 TABLET, FILM COATED in 1 BOTTLE (71610-651-60) 2022-06-200000-00-00NoNoCurrent
71610-651-7371610065173135 TABLET, FILM COATED in 1 BOTTLE (71610-651-73) 2022-06-200000-00-00NoNoCurrent
71610-651-8071610065180180 TABLET, FILM COATED in 1 BOTTLE (71610-651-80) 2022-06-200000-00-00NoNoCurrent