FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
68180-986
11-digit product format
681800986
Labeler code
68180
Product ID
68180-986_37fc8b27-bf23-4fe6-8d44-5331bde5b466
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA077670
Marketing category
ANDA
Marketing start
2025-08-06
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sertraline Hydrochloride
Listing expiration
2027-12-31

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-986-01Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3028
68180-986-02Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9028
68180-986-03Sertraline Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50028
68180-986-04Sertraline Hydrochloride5000 in 1 BOTTLETABLET, FILM COATED500028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-986-01EA - Each68180-986afeef38c-0955-4f24-8600-fbcf5237da6212026-01-08
68180-986-02EA - Each68180-986139d518e-743f-49b6-a287-27490b51317612025-12-16
68180-986-03EA - Each68180-986310ea2a0-0868-4254-b98c-a9e8bf3b89e812025-10-14
68180-986-04EA - Each68180-98688813146-d0b3-4e61-a3af-3b86c376966212025-10-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SERTRALINE HYDROCHLORIDEACTIVE INGREDIENTUTI8907Y6XSERTRALINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]10
SERTRALINEACTIVE MOIETYQUC7NX6WMBSERTRALINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]10
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JSERTRALINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USERTRALINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSERTRALINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSERTRALINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSERTRALINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASERTRALINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSERTRALINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]10
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSERTRALINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSERTRALINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SERTRALINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASERTRALINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]10
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSERTRALINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SERTRALINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSERTRALINE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]10

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN42120ff8-b353-4632-9ea9-54de9a69872428
312940sertraline HCl 25 MG Oral TabletPSN42120ff8-b353-4632-9ea9-54de9a69872428
312941sertraline HCl 50 MG Oral TabletPSN42120ff8-b353-4632-9ea9-54de9a69872428
312938sertraline 100 MG Oral TabletSCD42120ff8-b353-4632-9ea9-54de9a69872428
312940sertraline 25 MG Oral TabletSCD42120ff8-b353-4632-9ea9-54de9a69872428
312941sertraline 50 MG Oral TabletSCD42120ff8-b353-4632-9ea9-54de9a69872428
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY42120ff8-b353-4632-9ea9-54de9a69872428
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY42120ff8-b353-4632-9ea9-54de9a69872428
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY42120ff8-b353-4632-9ea9-54de9a69872428
312941sertraline HCl 50 MG Oral TabletPSN5f0616f6-433f-45c9-86f4-f802fda5d89111
312941sertraline HCl 50 MG Oral TabletPSNb5e98b93-d8f8-4eed-8a0a-63b347b670ed11
312941sertraline 50 MG Oral TabletSCD5f0616f6-433f-45c9-86f4-f802fda5d89111
312941sertraline 50 MG Oral TabletSCDb5e98b93-d8f8-4eed-8a0a-63b347b670ed11
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYb5e98b93-d8f8-4eed-8a0a-63b347b670ed11
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY5f0616f6-433f-45c9-86f4-f802fda5d89111
312941sertraline HCl 50 MG Oral TabletPSNcac718b8-64bc-4aca-9b22-f2b00077bd415
312941sertraline 50 MG Oral TabletSCDcac718b8-64bc-4aca-9b22-f2b00077bd415
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYcac718b8-64bc-4aca-9b22-f2b00077bd415
312938sertraline HCl 100 MG Oral TabletPSNfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312940sertraline HCl 25 MG Oral TabletPSNfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312941sertraline HCl 50 MG Oral TabletPSNfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312938sertraline 100 MG Oral TabletSCDfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312940sertraline 25 MG Oral TabletSCDfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312941sertraline 50 MG Oral TabletSCDfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312938sertraline HCl 100 MG Oral TabletPSN40be43b2-649b-0928-e063-6394a90a3b481
312940sertraline HCl 25 MG Oral TabletPSN40be43b2-649b-0928-e063-6394a90a3b481
312941sertraline HCl 50 MG Oral TabletPSN40be43b2-649b-0928-e063-6394a90a3b481
312938sertraline 100 MG Oral TabletSCD40be43b2-649b-0928-e063-6394a90a3b481
312940sertraline 25 MG Oral TabletSCD40be43b2-649b-0928-e063-6394a90a3b481
312941sertraline 50 MG Oral TabletSCD40be43b2-649b-0928-e063-6394a90a3b481
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY40be43b2-649b-0928-e063-6394a90a3b481
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY40be43b2-649b-0928-e063-6394a90a3b481
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY40be43b2-649b-0928-e063-6394a90a3b481

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68180-986-016818009860130 TABLET, FILM COATED in 1 BOTTLE (68180-986-01) 2025-08-06NoNoHistorical
68180-986-026818009860290 TABLET, FILM COATED in 1 BOTTLE (68180-986-02) 2025-08-06NoNoHistorical
68180-986-0368180098603500 TABLET, FILM COATED in 1 BOTTLE (68180-986-03) 2025-08-06NoNoHistorical
68180-986-04681800986045000 TABLET, FILM COATED in 1 BOTTLE (68180-986-04) 2025-08-06NoNoHistorical