FDA.reportPublic FDA data

Sertraline

Product NDC
51655-352
11-digit product format
516550352
Labeler code
51655
Product ID
51655-352_035c8fa3-716d-4d70-a880-023fc4aa9372
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
ANDA077670
Marketing category
ANDA
Marketing start
2014-07-11
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-352-262026-01-04C16284748780-19d75b9d1-2220-f424-e053-dadaa90a57ce050dfd68-07f6-482f-a2f1-ec0fe4fdc3d2
51655-352-262020-01-31C16284748780-19d75b9d1-2220-f424-e053-dadaa90a57ce050dfd68-07f6-482f-a2f1-ec0fe4fdc3d2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SERTRALINE HYDROCHLORIDEACTIVE INGREDIENTUTI8907Y6XSERTRALINE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1
SERTRALINEACTIVE MOIETYQUC7NX6WMBSERTRALINE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-352SERTRALINE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1Legacy NDC20140723_050dfd68-07f6-482f-a2f1-ec0fe4fdc3d2.zip