FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
68180-978
11-digit product format
681800978
Labeler code
68180
Product ID
68180-978_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
2025-07-20
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
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 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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-978-01Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3028
68180-978-02Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9028
68180-978-03Sertraline Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-978-01EA - Each68180-97827e351be-3281-42e5-a1f1-c02bec03609412025-08-11
68180-978-02EA - Each68180-9788e0ee814-254a-430f-a607-a3dda398acb112025-08-11
68180-978-03EA - Each68180-978dafb8eea-4b24-4b1e-825e-bd02046b7d0212025-08-11

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
312940sertraline HCl 25 MG Oral TabletPSNa06f2cf6-ccef-47bf-aba8-a42bada46d8b9
312940sertraline HCl 25 MG Oral TabletPSN0de9e3e3-912a-428b-89d2-70811a56cdc59
312940sertraline 25 MG Oral TabletSCD0de9e3e3-912a-428b-89d2-70811a56cdc59
312940sertraline 25 MG Oral TabletSCDa06f2cf6-ccef-47bf-aba8-a42bada46d8b9
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY0de9e3e3-912a-428b-89d2-70811a56cdc59
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYa06f2cf6-ccef-47bf-aba8-a42bada46d8b9
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 TabletPSN4f94a6d7-8719-834c-e063-6294a90a34481
312940sertraline HCl 25 MG Oral TabletPSN40be43b2-649b-0928-e063-6394a90a3b481
312940sertraline HCl 25 MG Oral TabletPSN268bd7f7-bc17-4850-ab7c-1b73caa564d51
312941sertraline HCl 50 MG Oral TabletPSN40be43b2-649b-0928-e063-6394a90a3b481
312938sertraline 100 MG Oral TabletSCD40be43b2-649b-0928-e063-6394a90a3b481
312940sertraline 25 MG Oral TabletSCD268bd7f7-bc17-4850-ab7c-1b73caa564d51
312940sertraline 25 MG Oral TabletSCD4f94a6d7-8719-834c-e063-6294a90a34481
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 TabletSY4f94a6d7-8719-834c-e063-6294a90a34481
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY268bd7f7-bc17-4850-ab7c-1b73caa564d51
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
68180-978-016818009780130 TABLET, FILM COATED in 1 BOTTLE (68180-978-01) 2025-07-20NoNoCurrent
68180-978-026818009780290 TABLET, FILM COATED in 1 BOTTLE (68180-978-02) 2025-07-20NoNoCurrent
68180-978-03681800978031000 TABLET, FILM COATED in 1 BOTTLE (68180-978-03) 2025-07-20NoNoCurrent