FDA.reportPublic FDA data

SERTRALINE

Product NDC
43353-809
11-digit product format
433530809
Labeler code
43353
Product ID
43353-809_96f26cbd-961f-499a-accc-00b44c151b1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077397
Marketing category
ANDA
Marketing start
2012-08-20
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
4ac594ea-ad8b-47fd-9b52-bbd98301675eProduct name120220317
255fa467-900b-5557-4215-6823352d1150Product name220211028

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-809-152023-01-30C16284748780-1f386c649-bf67-0266-e053-dadaa90a7c1aSertraline Tablets, USP 25 mg, 50 mg and 100 mg Rx Only
43353-809-302023-01-30C16284748780-1f386c649-bf67-0266-e053-dadaa90a7c1aSertraline Tablets, USP 25 mg, 50 mg and 100 mg Rx Only
43353-809-452023-01-30C16284748780-1f386c649-bf67-0266-e053-dadaa90a7c1aSertraline Tablets, USP 25 mg, 50 mg and 100 mg Rx Only
43353-809-532023-01-30C16284748780-1f386c649-bf67-0266-e053-dadaa90a7c1aSertraline Tablets, USP 25 mg, 50 mg and 100 mg Rx Only
43353-809-602023-01-30C16284748780-1f386c649-bf67-0266-e053-dadaa90a7c1aSertraline Tablets, USP 25 mg, 50 mg and 100 mg Rx Only
43353-809-732023-01-30C16284748780-1f386c649-bf67-0266-e053-dadaa90a7c1aSertraline Tablets, USP 25 mg, 50 mg and 100 mg Rx Only
43353-809-802023-01-30C16284748780-1f386c649-bf67-0266-e053-dadaa90a7c1aSertraline Tablets, USP 25 mg, 50 mg and 100 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-809-15SERTRALINE15 in 1 BOTTLE, PLASTICTABLET, FILM COATED152
43353-809-30SERTRALINE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
43353-809-45SERTRALINE45 in 1 BOTTLE, PLASTICTABLET, FILM COATED452
43353-809-53SERTRALINE60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
43353-809-60SERTRALINE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902
43353-809-73SERTRALINE135 in 1 BOTTLE, PLASTICTABLET, FILM COATED1352
43353-809-80SERTRALINE180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-809-15EA - Each43353-8097c77d7ba-29e0-49ef-a5d9-15e76061dd1912014-07-02
43353-809-30EA - Each43353-809640d9747-8a78-4972-b627-cc22598d5ac112014-07-02
43353-809-45EA - Each43353-809d48b1b77-aca3-4b78-9a99-fb4739e550a312014-07-02
43353-809-53EA - Each43353-809dfec1375-2ec8-4381-803a-76a4052e6eb412014-07-02
43353-809-60EA - Each43353-809efafbeee-cfbc-4685-a975-491f12a25c1d12014-07-02
43353-809-73EA - Each43353-8093b8b4af8-fc5c-4f64-995c-783fe3d103d412014-07-02
43353-809-80EA - Each43353-809c3bbb72b-0ddb-467d-b2ed-dc3a57b8db2112014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SERTRALINE HYDROCHLORIDEACTIVE INGREDIENTUTI8907Y6XSERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SERTRALINEACTIVE MOIETYQUC7NX6WMBSERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LSERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-809SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 7 package rows20191224_c01ed291-3c4f-4285-b54d-d15d39327b21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSNc01ed291-3c4f-4285-b54d-d15d39327b212
312940sertraline HCl 25 MG Oral TabletPSNc01ed291-3c4f-4285-b54d-d15d39327b212
312941sertraline HCl 50 MG Oral TabletPSNc01ed291-3c4f-4285-b54d-d15d39327b212
312938sertraline 100 MG Oral TabletSCDc01ed291-3c4f-4285-b54d-d15d39327b212
312940sertraline 25 MG Oral TabletSCDc01ed291-3c4f-4285-b54d-d15d39327b212
312941sertraline 50 MG Oral TabletSCDc01ed291-3c4f-4285-b54d-d15d39327b212
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYc01ed291-3c4f-4285-b54d-d15d39327b212
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYc01ed291-3c4f-4285-b54d-d15d39327b212
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYc01ed291-3c4f-4285-b54d-d15d39327b212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-809-154335308091515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-809-15) 2012-10-290000-00-00NoNoCurrent
43353-809-304335308093030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-809-30) 2012-10-290000-00-00NoNoCurrent
43353-809-454335308094545 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-809-45) 2012-10-290000-00-00NoNoCurrent
43353-809-534335308095360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-809-53) 2012-10-290000-00-00NoNoCurrent
43353-809-604335308096090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-809-60) 2012-10-290000-00-00NoNoCurrent
43353-809-7343353080973135 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-809-73) 2012-10-290000-00-00NoNoCurrent
43353-809-8043353080980180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-809-80) 2012-10-290000-00-00NoNoCurrent