FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
60687-242
11-digit product format
606870242
Labeler code
60687
Product ID
60687-242_249c2c66-cd55-acd8-e063-6394a90ad0f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA077397
Marketing category
ANDA
Marketing start
2017-01-11
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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SERTRALINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUTI8907Y6X
Rxcui312938, 312940, 312941

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
4ac594ea-ad8b-47fd-9b52-bbd98301675eProduct name120220317
255fa467-900b-5557-4215-6823352d1150Product name220211028

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-242-01Sertraline Hydrochloride100 in 1 BOX, UNIT-DOSETABLET1007
60687-242-11Sertraline Hydrochloride1 in 1 BLISTER PACKTABLET17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-242-01EA - Each60687-242656a743f-caec-4add-a523-13d732b0f66d12017-03-06
60687-242-11EA - Each60687-242c412b32e-e25a-4851-a56f-4ab24d0836b312017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-242SERTRALINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]7Current NDC, Legacy NDC, 2 package rows20241122_4e09f580-d612-416c-a4a4-79a4411845b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN7e5e76cf-2fda-4f9d-bcbf-f77b1f188ee68
312941sertraline HCl 50 MG Oral TabletPSN7e5e76cf-2fda-4f9d-bcbf-f77b1f188ee68
312938sertraline 100 MG Oral TabletSCD7e5e76cf-2fda-4f9d-bcbf-f77b1f188ee68
312941sertraline 50 MG Oral TabletSCD7e5e76cf-2fda-4f9d-bcbf-f77b1f188ee68
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY7e5e76cf-2fda-4f9d-bcbf-f77b1f188ee68
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY7e5e76cf-2fda-4f9d-bcbf-f77b1f188ee68
312938sertraline HCl 100 MG Oral TabletPSN4e09f580-d612-416c-a4a4-79a4411845b27
312940sertraline HCl 25 MG Oral TabletPSN4e09f580-d612-416c-a4a4-79a4411845b27
312941sertraline HCl 50 MG Oral TabletPSN4e09f580-d612-416c-a4a4-79a4411845b27
312938sertraline 100 MG Oral TabletSCD4e09f580-d612-416c-a4a4-79a4411845b27
312940sertraline 25 MG Oral TabletSCD4e09f580-d612-416c-a4a4-79a4411845b27
312941sertraline 50 MG Oral TabletSCD4e09f580-d612-416c-a4a4-79a4411845b27
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY4e09f580-d612-416c-a4a4-79a4411845b27
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY4e09f580-d612-416c-a4a4-79a4411845b27
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY4e09f580-d612-416c-a4a4-79a4411845b27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-242-0160687024201100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-242-01) / 1 TABLET in 1 BLISTER PACK (60687-242-11) 100 blister pack2017-01-110000-00-00NoNoCurrent
60687-242-11606870242111 in 1 BLISTER PACKHistorical