FDA.reportPublic FDA data

SERTRALINE HYDROCHLORIDE

Product NDC
16729-216
11-digit product format
167290216
Labeler code
16729
Product ID
16729-216_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
50 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 HYDROCHLORIDE50 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
16729-216-01SERTRALINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED10019
16729-216-10SERTRALINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED3019
16729-216-15SERTRALINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED9019
16729-216-16SERTRALINE HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED50019
16729-216-43SERTRALINE 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
16729-216-15EA - Each16729-216244cfc50-a442-4123-bebc-3fe1dd4c1f7812017-03-06
16729-216-16EA - Each16729-21603832b5b-daa3-4a2f-90be-0c1e4075fed312017-03-06

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
16729-216SERTRALINE 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
312941sertraline HCl 50 MG Oral TabletPSNaa13261f-46a7-4381-8084-b3ad46221e2f21
312941sertraline 50 MG Oral TabletSCDaa13261f-46a7-4381-8084-b3ad46221e2f21
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYaa13261f-46a7-4381-8084-b3ad46221e2f21
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
312941sertraline HCl 50 MG Oral TabletPSN82a44e20-d0ee-4ed7-9234-24ef4496ac1d14
312941sertraline 50 MG Oral TabletSCD82a44e20-d0ee-4ed7-9234-24ef4496ac1d14
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY82a44e20-d0ee-4ed7-9234-24ef4496ac1d14
312941sertraline HCl 50 MG Oral TabletPSNdc97a895-8c2f-4891-85f3-7f45e23961407
312941sertraline 50 MG Oral TabletSCDdc97a895-8c2f-4891-85f3-7f45e23961407
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYdc97a895-8c2f-4891-85f3-7f45e23961407
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
312941sertraline HCl 50 MG Oral TabletPSN76a3da84-aafb-a9b6-e053-2991aa0a5b0b4
312941sertraline 50 MG Oral TabletSCD76a3da84-aafb-a9b6-e053-2991aa0a5b0b4
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY76a3da84-aafb-a9b6-e053-2991aa0a5b0b4
312938sertraline HCl 100 MG Oral TabletPSN6b532e6a-b040-4a10-a242-fb6d8dfc08523
312941sertraline HCl 50 MG Oral TabletPSN8fefed07-ea11-0482-e053-2995a90a87d43
312941sertraline HCl 50 MG Oral TabletPSN5b453bcb-b110-4993-e053-2991aa0a87793
312941sertraline HCl 50 MG Oral TabletPSN6b532e6a-b040-4a10-a242-fb6d8dfc08523
312938sertraline 100 MG Oral TabletSCD6b532e6a-b040-4a10-a242-fb6d8dfc08523
312941sertraline 50 MG Oral TabletSCD6b532e6a-b040-4a10-a242-fb6d8dfc08523
312941sertraline 50 MG Oral TabletSCD5b453bcb-b110-4993-e053-2991aa0a87793
312941sertraline 50 MG Oral TabletSCD8fefed07-ea11-0482-e053-2995a90a87d43
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY6b532e6a-b040-4a10-a242-fb6d8dfc08523
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY6b532e6a-b040-4a10-a242-fb6d8dfc08523
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY8fefed07-ea11-0482-e053-2995a90a87d43
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY5b453bcb-b110-4993-e053-2991aa0a87793
312941sertraline HCl 50 MG Oral TabletPSN146ab1fa-b0ac-46e6-a4d1-83db93794c322
312941sertraline 50 MG Oral TabletSCD146ab1fa-b0ac-46e6-a4d1-83db93794c322
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY146ab1fa-b0ac-46e6-a4d1-83db93794c322
312941sertraline HCl 50 MG Oral TabletPSN675fea8e-6eb4-86ce-e053-2991aa0a0a881
312941sertraline 50 MG Oral TabletSCD675fea8e-6eb4-86ce-e053-2991aa0a0a881
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY675fea8e-6eb4-86ce-e053-2991aa0a0a881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-216-0116729021601100 in 1 BOTTLEHistorical
16729-216-101672902161030 in 1 BOTTLEHistorical
16729-216-151672902161590 TABLET, FILM COATED in 1 BOTTLE (16729-216-15) 2017-02-090000-00-00NoNoCurrent
16729-216-1616729021616500 TABLET, FILM COATED in 1 BOTTLE (16729-216-16) 2017-02-130000-00-00NoNoCurrent
16729-216-4316729021643100 in 1 BOX, UNIT-DOSEHistorical