FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
63304-166
11-digit product format
633040166
Labeler code
63304
Product ID
63304-166_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
100 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
63304-166-012020-01-31C16284748780-19d75b9cf-d175-f424-e053-dadaa90a57ceSERTRALINE HYDROCHLORIDE TABLETS Rx only
63304-166-032020-01-31C16284748780-19d75b9cf-d175-f424-e053-dadaa90a57ceSERTRALINE HYDROCHLORIDE TABLETS Rx only
63304-166-052020-01-31C16284748780-19d75b9cf-d175-f424-e053-dadaa90a57ceSERTRALINE HYDROCHLORIDE TABLETS Rx only
63304-166-302020-01-31C16284748780-19d75b9cf-d175-f424-e053-dadaa90a57ceSERTRALINE HYDROCHLORIDE TABLETS Rx only
63304-166-522020-01-31C16284748780-19d75b9cf-d175-f424-e053-dadaa90a57ceSERTRALINE HYDROCHLORIDE TABLETS Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-166-01Sertraline Hydrochloride100 in 1 BOTTLETABLET, COATED1006
63304-166-03Sertraline Hydrochloride10 in 1 BOTTLETABLET, COATED106
63304-166-05Sertraline Hydrochloride500 in 1 BOTTLETABLET, COATED5006
63304-166-30Sertraline Hydrochloride30 in 1 BOTTLETABLET, COATED306
63304-166-52Sertraline Hydrochloride2500 in 1 BOTTLETABLET, COATED25006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-166-01EA - Each63304-166398b58be-ad5f-47d3-bd1c-4bbd7212692d12013-02-11
63304-166-05EA - Each63304-1665b6dac16-854b-412d-b294-d72680923bbc12013-02-11
63304-166-30EA - Each63304-166f3b94018-82d0-494b-9dd1-0b562dcd053712013-02-11

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
63304-166SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]6Legacy NDC, 5 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
63304-166-0163304016601100 in 1 BOTTLEHistorical
63304-166-036330401660310 in 1 BOTTLEHistorical
63304-166-0563304016605500 in 1 BOTTLEHistorical
63304-166-306330401663030 in 1 BOTTLEHistorical
63304-166-52633040166522500 in 1 BOTTLEHistorical