FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
50090-2080
11-digit product format
500902080
Labeler code
50090
Product ID
50090-2080_43075090-6322-4467-bfb2-acc0b0c9c786
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077206
Marketing category
ANDA
Marketing start
2007-02-06
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, 312940, 312941

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ac594ea-ad8b-47fd-9b52-bbd98301675eProduct name120220317
255fa467-900b-5557-4215-6823352d1150Product name220211028

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2080-02023-02-23C16284748780-1f386c649-d01c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
50090-2080-12023-02-23C16284748780-1f386c649-d01c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
50090-2080-22023-02-23C16284748780-1f386c649-d01c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
50090-2080-02023-01-30C16284748780-1f386c649-d01c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
50090-2080-12023-01-30C16284748780-1f386c649-d01c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
50090-2080-22023-01-30C16284748780-1f386c649-d01c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2080-0Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3037
50090-2080-1Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6037
50090-2080-2Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9037

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2080-0EA - Each50090-20806da13105-3b14-45fb-b3dc-03f24bbb12e212019-02-13
50090-2080-1EA - Each50090-2080f48077a1-7019-4fa9-8e39-69b987eb0b5712019-02-13
50090-2080-2EA - Each50090-208023d3fcf3-1ab4-4556-8663-1d0ef1c269f412019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2080SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]37Current NDC, Legacy NDC, 3 package rows20230911_286b429d-62b9-4ca8-a243-de3f619315bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN286b429d-62b9-4ca8-a243-de3f619315bf37
312940sertraline HCl 25 MG Oral TabletPSN286b429d-62b9-4ca8-a243-de3f619315bf37
312941sertraline HCl 50 MG Oral TabletPSN286b429d-62b9-4ca8-a243-de3f619315bf37
312938sertraline 100 MG Oral TabletSCD286b429d-62b9-4ca8-a243-de3f619315bf37
312940sertraline 25 MG Oral TabletSCD286b429d-62b9-4ca8-a243-de3f619315bf37
312941sertraline 50 MG Oral TabletSCD286b429d-62b9-4ca8-a243-de3f619315bf37
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY286b429d-62b9-4ca8-a243-de3f619315bf37
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY286b429d-62b9-4ca8-a243-de3f619315bf37
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY286b429d-62b9-4ca8-a243-de3f619315bf37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2080-05009020800030 TABLET, FILM COATED in 1 BOTTLE (50090-2080-0) 2015-10-080000-00-00NoNoCurrent
50090-2080-15009020800160 TABLET, FILM COATED in 1 BOTTLE (50090-2080-1) 2015-10-080000-00-00NoNoCurrent
50090-2080-25009020800290 TABLET, FILM COATED in 1 BOTTLE (50090-2080-2) 2015-10-080000-00-00NoNoCurrent