FDA.reportPublic FDA data

SERTRALINE HYDROCHLORIDE

Product NDC
16729-215
11-digit product format
167290215
Labeler code
16729
Product ID
16729-215_46293a9f-fad8-a06b-e063-6294a90acb9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SERTRALINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare, Inc.
Application
ANDA202825
Marketing category
ANDA
Marketing start
2017-02-09
Substance
SERTRALINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SERTRALINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SERTRALINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUTI8907Y6X
Rxcui312938, 312940, 312941

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ac594ea-ad8b-47fd-9b52-bbd98301675eProduct name120220317
255fa467-900b-5557-4215-6823352d1150Product name220211028

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-215-10SERTRALINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED3019
16729-215-11SERTRALINE HYDROCHLORIDE50 in 1 BOTTLETABLET, FILM COATED5019
16729-215-15SERTRALINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED9019
16729-215-16SERTRALINE HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED50019
16729-215-43SERTRALINE HYDROCHLORIDE100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-215-10EA - Each16729-215bb8df575-8999-41cb-bf98-696fd60aea8212017-03-06
16729-215-15EA - Each16729-21578be32bc-7cc1-4a1c-b961-8645a819108a12018-07-03
16729-215-16EA - Each16729-215cf65d53c-1a66-46d8-af47-d86993242a7512018-07-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SERTRALINE HYDROCHLORIDEACTIVE INGREDIENTUTI8907Y6XSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
SERTRALINEACTIVE MOIETYQUC7NX6WMBSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
HYDROXYPROPYL CELLULOSE (TYPE L)INACTIVE INGREDIENTUKE75GEA7FSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-215SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]17Current NDC, Legacy NDC, 5 package rows20240106_205ecf52-8138-44a7-ad9a-b3aa7f4fa11a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312940sertraline HCl 25 MG Oral TabletPSNe919f195-0ce1-4d71-9883-efec05b9a050102
312940sertraline 25 MG Oral TabletSCDe919f195-0ce1-4d71-9883-efec05b9a050102
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYe919f195-0ce1-4d71-9883-efec05b9a050102
312938sertraline HCl 100 MG Oral TabletPSN205ecf52-8138-44a7-ad9a-b3aa7f4fa11a19
312940sertraline HCl 25 MG Oral TabletPSN205ecf52-8138-44a7-ad9a-b3aa7f4fa11a19
312941sertraline HCl 50 MG Oral TabletPSN205ecf52-8138-44a7-ad9a-b3aa7f4fa11a19
312938sertraline 100 MG Oral TabletSCD205ecf52-8138-44a7-ad9a-b3aa7f4fa11a19
312940sertraline 25 MG Oral TabletSCD205ecf52-8138-44a7-ad9a-b3aa7f4fa11a19
312941sertraline 50 MG Oral TabletSCD205ecf52-8138-44a7-ad9a-b3aa7f4fa11a19
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY205ecf52-8138-44a7-ad9a-b3aa7f4fa11a19
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY205ecf52-8138-44a7-ad9a-b3aa7f4fa11a19
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY205ecf52-8138-44a7-ad9a-b3aa7f4fa11a19
312940sertraline HCl 25 MG Oral TabletPSN3423456b-6a0f-4406-b910-a3dc9d3ffadd8
312940sertraline 25 MG Oral TabletSCD3423456b-6a0f-4406-b910-a3dc9d3ffadd8
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY3423456b-6a0f-4406-b910-a3dc9d3ffadd8
312938sertraline HCl 100 MG Oral TabletPSNd1324ef1-073f-41bb-a4fd-403f3619958b5
312940sertraline HCl 25 MG Oral TabletPSNd1324ef1-073f-41bb-a4fd-403f3619958b5
312941sertraline HCl 50 MG Oral TabletPSNd1324ef1-073f-41bb-a4fd-403f3619958b5
312938sertraline 100 MG Oral TabletSCDd1324ef1-073f-41bb-a4fd-403f3619958b5
312940sertraline 25 MG Oral TabletSCDd1324ef1-073f-41bb-a4fd-403f3619958b5
312941sertraline 50 MG Oral TabletSCDd1324ef1-073f-41bb-a4fd-403f3619958b5
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYd1324ef1-073f-41bb-a4fd-403f3619958b5
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYd1324ef1-073f-41bb-a4fd-403f3619958b5
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYd1324ef1-073f-41bb-a4fd-403f3619958b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-215-101672902151030 TABLET, FILM COATED in 1 BOTTLE (16729-215-10) 2017-02-090000-00-00NoNoCurrent
16729-215-111672902151150 in 1 BOTTLEHistorical
16729-215-151672902151590 TABLET, FILM COATED in 1 BOTTLE (16729-215-15) 2018-07-230000-00-00NoNoCurrent
16729-215-1616729021516500 TABLET, FILM COATED in 1 BOTTLE (16729-215-16) 2018-08-030000-00-00NoNoCurrent
16729-215-4316729021543100 in 1 BOX, UNIT-DOSEHistorical