FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
63304-164
11-digit product format
633040164
Labeler code
63304
Product ID
63304-164_d75e7077-98f9-41d8-860c-39d556cc7a1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Ranbaxy Pharmaceuticals Inc.
Application
ANDA077977
Marketing category
ANDA
Marketing start
2007-02-06
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
No
Listing certified through
2019-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63304-164-032020-01-31C16284748780-19d75b9cf-d175-f424-e053-dadaa90a57ceSERTRALINE HYDROCHLORIDE TABLETS Rx only
63304-164-302020-01-31C16284748780-19d75b9cf-d175-f424-e053-dadaa90a57ceSERTRALINE HYDROCHLORIDE TABLETS Rx only
63304-164-502020-01-31C16284748780-19d75b9cf-d175-f424-e053-dadaa90a57ceSERTRALINE HYDROCHLORIDE TABLETS Rx only
63304-164-522020-01-31C16284748780-19d75b9cf-d175-f424-e053-dadaa90a57ceSERTRALINE HYDROCHLORIDE TABLETS Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-164-03Sertraline Hydrochloride10 in 1 BOTTLETABLET, COATED106
63304-164-30Sertraline Hydrochloride30 in 1 BOTTLETABLET, COATED306
63304-164-50Sertraline Hydrochloride50 in 1 BOTTLETABLET, COATED506
63304-164-52Sertraline Hydrochloride2500 in 1 BOTTLETABLET, COATED25006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-164-30EA - Each63304-16472f72687-1c3f-4b02-b692-13bff652314512013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SERTRALINE HYDROCHLORIDEACTIVE INGREDIENTUTI8907Y6XSERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]5
SERTRALINEACTIVE MOIETYQUC7NX6WMBSERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]5
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1USERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-164SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]6Legacy NDC, 4 package rows20160108_c25f968b-7037-4f60-9a02-2189769b0cbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSNc25f968b-7037-4f60-9a02-2189769b0cbf6
794947sertraline HCl 150 MG Oral TabletPSNc25f968b-7037-4f60-9a02-2189769b0cbf6
251200sertraline HCl 200 MG Oral TabletPSNc25f968b-7037-4f60-9a02-2189769b0cbf6
312940sertraline HCl 25 MG Oral TabletPSNc25f968b-7037-4f60-9a02-2189769b0cbf6
312941sertraline HCl 50 MG Oral TabletPSNc25f968b-7037-4f60-9a02-2189769b0cbf6
312938sertraline 100 MG Oral TabletSCDc25f968b-7037-4f60-9a02-2189769b0cbf6
794947sertraline 150 MG Oral TabletSCDc25f968b-7037-4f60-9a02-2189769b0cbf6
251200sertraline 200 MG Oral TabletSCDc25f968b-7037-4f60-9a02-2189769b0cbf6
312940sertraline 25 MG Oral TabletSCDc25f968b-7037-4f60-9a02-2189769b0cbf6
312941sertraline 50 MG Oral TabletSCDc25f968b-7037-4f60-9a02-2189769b0cbf6
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYc25f968b-7037-4f60-9a02-2189769b0cbf6
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYc25f968b-7037-4f60-9a02-2189769b0cbf6
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYc25f968b-7037-4f60-9a02-2189769b0cbf6
794947sertraline (as sertraline hydrochloride) 150 MG Oral TabletSYc25f968b-7037-4f60-9a02-2189769b0cbf6
251200sertraline (as sertraline hydrochloride) 200 MG Oral TabletSYc25f968b-7037-4f60-9a02-2189769b0cbf6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63304-164-036330401640310 in 1 BOTTLEHistorical
63304-164-306330401643030 in 1 BOTTLEHistorical
63304-164-506330401645050 in 1 BOTTLEHistorical
63304-164-52633040164522500 in 1 BOTTLEHistorical