Sertraline Hydrochloride

Product NDC
13107-011
11-digit product format
131070011
Labeler code
13107
Product ID
13107-011_966d728e-87ca-4491-9411-2ec253eca632
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aurolife Pharma LLC
Application
ANDA077206
Marketing category
ANDA
Marketing start
2011-03-15
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13107-011-01Sertraline Hydrochloride100 in 1 BOTTLETABLET1001
13107-011-05Sertraline Hydrochloride500 in 1 BOTTLETABLET5001
13107-011-30Sertraline Hydrochloride30 in 1 BOTTLETABLET301
13107-011-50Sertraline Hydrochloride50 in 1 BOTTLETABLET501
13107-011-51Sertraline Hydrochloride5000 in 1 BOTTLETABLET50001
13107-011-60Sertraline Hydrochloride60 in 1 BOTTLETABLET601
13107-011-90Sertraline Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SERTRALINE HYDROCHLORIDEACTIVE INGREDIENTUTI8907Y6XSERTRALINE HYDROCHLORIDE TABLET [AUROLIFE PHARMA LLC]1
SERTRALINEACTIVE MOIETYQUC7NX6WMBSERTRALINE HYDROCHLORIDE TABLET [AUROLIFE PHARMA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USERTRALINE HYDROCHLORIDE TABLET [AUROLIFE PHARMA LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSERTRALINE HYDROCHLORIDE TABLET [AUROLIFE PHARMA LLC]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSERTRALINE HYDROCHLORIDE TABLET [AUROLIFE PHARMA LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSERTRALINE HYDROCHLORIDE TABLET [AUROLIFE PHARMA LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSERTRALINE HYDROCHLORIDE TABLET [AUROLIFE PHARMA LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASERTRALINE HYDROCHLORIDE TABLET [AUROLIFE PHARMA LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSERTRALINE HYDROCHLORIDE TABLET [AUROLIFE PHARMA LLC]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSERTRALINE HYDROCHLORIDE TABLET [AUROLIFE PHARMA LLC]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6SERTRALINE HYDROCHLORIDE TABLET [AUROLIFE PHARMA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SERTRALINE HYDROCHLORIDE TABLET [AUROLIFE PHARMA LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSERTRALINE HYDROCHLORIDE TABLET [AUROLIFE PHARMA LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSERTRALINE HYDROCHLORIDE TABLET [AUROLIFE PHARMA LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SERTRALINE HYDROCHLORIDE TABLET [AUROLIFE PHARMA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSERTRALINE HYDROCHLORIDE TABLET [AUROLIFE PHARMA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-011SERTRALINE HYDROCHLORIDE TABLET [AUROLIFE PHARMA LLC]1Legacy NDC, 7 package rows20110815_966d728e-87ca-4491-9411-2ec253eca632.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN966d728e-87ca-4491-9411-2ec253eca6321
312940sertraline HCl 25 MG Oral TabletPSN966d728e-87ca-4491-9411-2ec253eca6321
312941sertraline HCl 50 MG Oral TabletPSN966d728e-87ca-4491-9411-2ec253eca6321
312938sertraline 100 MG Oral TabletSCD966d728e-87ca-4491-9411-2ec253eca6321
312940sertraline 25 MG Oral TabletSCD966d728e-87ca-4491-9411-2ec253eca6321
312941sertraline 50 MG Oral TabletSCD966d728e-87ca-4491-9411-2ec253eca6321
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY966d728e-87ca-4491-9411-2ec253eca6321
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY966d728e-87ca-4491-9411-2ec253eca6321
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY966d728e-87ca-4491-9411-2ec253eca6321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
13107-011-0113107001101100 in 1 BOTTLEHistorical
13107-011-0513107001105500 in 1 BOTTLEHistorical
13107-011-301310700113030 in 1 BOTTLEHistorical
13107-011-501310700115050 in 1 BOTTLEHistorical
13107-011-51131070011515000 in 1 BOTTLEHistorical
13107-011-601310700116060 in 1 BOTTLEHistorical
13107-011-901310700119090 in 1 BOTTLEHistorical