FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
51655-345
11-digit product format
516550345
Labeler code
51655
Product ID
51655-345_48eb422d-bc39-d06b-e063-6294a90af655
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA077397
Marketing category
ANDA
Marketing start
2020-05-28
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
Rxcui312940

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
51655-345-262023-11-14C16284748780-1f386c64a-2e4c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SERTRALINE TABLETS safely and effectively. See full prescribing information for SERTRALINE TABLETS. SERTRALINE tablets, for oral use Initial U.S. Approval: 1991
51655-345-262023-01-30C16284748780-1f386c64a-2e4c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SERTRALINE TABLETS safely and effectively. See full prescribing information for SERTRALINE TABLETS. SERTRALINE tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-345-26Sertraline Hydrochloride90 in 1 BOTTLE, PLASTICTABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-345SERTRALINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 1 package rows20241219_ab30b0a4-6696-19da-e053-2995a90a29aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312940sertraline HCl 25 MG Oral TabletPSNab30b0a4-6696-19da-e053-2995a90a29aa5
312940sertraline 25 MG Oral TabletSCDab30b0a4-6696-19da-e053-2995a90a29aa5
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYab30b0a4-6696-19da-e053-2995a90a29aa5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-345-265165503452690 TABLET in 1 BOTTLE, PLASTIC (51655-345-26) 90 tablet2020-05-280000-00-00NoNoCurrent