FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
50090-2071
11-digit product format
500902071
Labeler code
50090
Product ID
50090-2071_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
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
4ac594ea-ad8b-47fd-9b52-bbd98301675eProduct name120220317
255fa467-900b-5557-4215-6823352d1150Product name220211028

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2071-0Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3037
50090-2071-1Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6037
50090-2071-2Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9037

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2071-0EA - Each50090-207194679e20-e60c-4439-9273-27621936ab2812019-02-13
50090-2071-1EA - Each50090-207198364c10-2a4e-4a87-8d00-58ac08753a4412019-02-13
50090-2071-2EA - Each50090-2071470fc0df-bee4-4be1-a3c3-2c7d5ce06e4712019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2071SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]37Current 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 startSampleExclude flagStatus
50090-2071-05009020710030 TABLET, FILM COATED in 1 BOTTLE (50090-2071-0) 2015-10-07NoNoCurrent
50090-2071-15009020710160 TABLET, FILM COATED in 1 BOTTLE (50090-2071-1) 2015-10-07NoNoCurrent
50090-2071-25009020710290 TABLET, FILM COATED in 1 BOTTLE (50090-2071-2) 2015-10-07NoNoCurrent