FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
68788-4045
11-digit product format
687884045
Labeler code
68788
Product ID
68788-4045_8f5a71b2-2821-46a0-ac65-28d9b2db73ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077206
Marketing category
ANDA
Marketing start
2025-10-17
Substance
SERTRALINE HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUTI8907Y6X
Rxcui312940

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
68788-4045-1Sertraline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001
68788-4045-3Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
68788-4045-6Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
68788-4045-9Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4045-1EA - Each68788-4045aab0918f-b430-474b-aa1b-b3ed1092cbdc12026-01-08
68788-4045-3EA - Each68788-40453f89a0de-2430-4a8d-a479-5fed1568adbb12026-01-08
68788-4045-6EA - Each68788-4045655535e3-f94a-4f29-b2e3-d7be80397ca612026-01-08
68788-4045-9EA - Each68788-404531537e6b-1aef-45e1-a43f-eb9d1aa1975c12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312940sertraline HCl 25 MG Oral TabletPSN8f5a71b2-2821-46a0-ac65-28d9b2db73ec1
312940sertraline 25 MG Oral TabletSCD8f5a71b2-2821-46a0-ac65-28d9b2db73ec1
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY8f5a71b2-2821-46a0-ac65-28d9b2db73ec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-4045-168788404501100 TABLET, FILM COATED in 1 BOTTLE (68788-4045-1) 2025-10-17NoNoCurrent
68788-4045-36878840450330 TABLET, FILM COATED in 1 BOTTLE (68788-4045-3) 2025-10-17NoNoCurrent
68788-4045-66878840450660 TABLET, FILM COATED in 1 BOTTLE (68788-4045-6) 2025-10-17NoNoCurrent
68788-4045-96878840450990 TABLET, FILM COATED in 1 BOTTLE (68788-4045-9) 2025-10-17NoNoCurrent