FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
68645-521
11-digit product format
686450521
Labeler code
68645
Product ID
68645-521_4cc29310-2a31-9e2e-e063-6294a90a8e5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Legacy Pharmaceutical Packaging, LLC
Application
ANDA077397
Marketing category
ANDA
Marketing start
2016-07-21
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sertraline Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SERTRALINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUTI8907Y6X
Rxcui312938, 312940, 312941

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
68645-521-54Sertraline Hydrochloride30 in 1 BOTTLETABLET3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68645-521-01EA - Each68645-521451947a7-99eb-47c7-b7f1-efaeb1957ee312016-10-06
68645-521-54EA - Each68645-521c6427edf-547e-4251-879f-532dd783036512016-11-08
68645-521-70EA - Each68645-521bae6a631-23ef-461e-a53b-884b16f4a29512016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68645-521SERTRALINE HYDROCHLORIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC]15Current NDC, Legacy NDC, 1 package rows20250425_bd86b293-dab9-4d37-95eb-2bffca335d16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSNbd86b293-dab9-4d37-95eb-2bffca335d1616
312940sertraline HCl 25 MG Oral TabletPSNbd86b293-dab9-4d37-95eb-2bffca335d1616
312941sertraline HCl 50 MG Oral TabletPSNbd86b293-dab9-4d37-95eb-2bffca335d1616
312938sertraline 100 MG Oral TabletSCDbd86b293-dab9-4d37-95eb-2bffca335d1616
312940sertraline 25 MG Oral TabletSCDbd86b293-dab9-4d37-95eb-2bffca335d1616
312941sertraline 50 MG Oral TabletSCDbd86b293-dab9-4d37-95eb-2bffca335d1616
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYbd86b293-dab9-4d37-95eb-2bffca335d1616
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYbd86b293-dab9-4d37-95eb-2bffca335d1616
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYbd86b293-dab9-4d37-95eb-2bffca335d1616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68645-521-546864505215430 TABLET in 1 BOTTLE (68645-521-54) 30 tablet2016-07-210000-00-00NoNoCurrent