FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
68180-351
11-digit product format
681800351
Labeler code
68180
Product ID
68180-351_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
2007-02-06
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
68180-351-01Sertraline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10028
68180-351-03Sertraline Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100028
68180-351-06Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3028
68180-351-08Sertraline Hydrochloride50 in 1 BOTTLETABLET, FILM COATED5028
68180-351-09Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-351-03EA - Each68180-35192479140-91be-43e4-8f4c-3e7c91d2872e12018-04-19
68180-351-06EA - Each68180-351e26e707c-bf86-462f-9b93-756a97f6be6812012-07-24
68180-351-09EA - Each68180-351c907f61b-c9b9-4d09-add5-a44e1a6626ed12012-07-24

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
SERTRALINE HYDROCHLORIDEACTIVE INGREDIENTUTI8907Y6XSERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]5
SERTRALINEACTIVE MOIETYQUC7NX6WMBSERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]5
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]5
SERTRALINE HYDROCHLORIDEACTIVE INGREDIENTUTI8907Y6XSERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
SERTRALINEACTIVE MOIETYQUC7NX6WMBSERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-351SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]24Current NDC, Legacy NDC, 5 package rows20250501_42120ff8-b353-4632-9ea9-54de9a698724.zip

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 TabletPSNcbc2bd3b-03fc-47b9-91d1-8989ec90c7e615
312940sertraline 25 MG Oral TabletSCDcbc2bd3b-03fc-47b9-91d1-8989ec90c7e615
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYcbc2bd3b-03fc-47b9-91d1-8989ec90c7e615
312940sertraline HCl 25 MG Oral TabletPSNe93391c9-db88-4fa5-b1d5-f6c6de78b31c11
312940sertraline 25 MG Oral TabletSCDe93391c9-db88-4fa5-b1d5-f6c6de78b31c11
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYe93391c9-db88-4fa5-b1d5-f6c6de78b31c11
312938sertraline HCl 100 MG Oral TabletPSN35dea1a2-ec26-4e52-8f09-ee4678e779469
312940sertraline HCl 25 MG Oral TabletPSN35dea1a2-ec26-4e52-8f09-ee4678e779469
312941sertraline HCl 50 MG Oral TabletPSN35dea1a2-ec26-4e52-8f09-ee4678e779469
312938sertraline 100 MG Oral TabletSCD35dea1a2-ec26-4e52-8f09-ee4678e779469
312940sertraline 25 MG Oral TabletSCD35dea1a2-ec26-4e52-8f09-ee4678e779469
312941sertraline 50 MG Oral TabletSCD35dea1a2-ec26-4e52-8f09-ee4678e779469
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY35dea1a2-ec26-4e52-8f09-ee4678e779469
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY35dea1a2-ec26-4e52-8f09-ee4678e779469
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY35dea1a2-ec26-4e52-8f09-ee4678e779469
312938sertraline HCl 100 MG Oral TabletPSN4cf8d5c8-842b-4e7c-9a99-3f41ef8abbdb8
312940sertraline HCl 25 MG Oral TabletPSN4cf8d5c8-842b-4e7c-9a99-3f41ef8abbdb8
312940sertraline HCl 25 MG Oral TabletPSNf515d1e7-5803-4797-b3cc-8dbea85d96e58
312941sertraline HCl 50 MG Oral TabletPSN4cf8d5c8-842b-4e7c-9a99-3f41ef8abbdb8
312938sertraline 100 MG Oral TabletSCD4cf8d5c8-842b-4e7c-9a99-3f41ef8abbdb8
312940sertraline 25 MG Oral TabletSCD4cf8d5c8-842b-4e7c-9a99-3f41ef8abbdb8
312940sertraline 25 MG Oral TabletSCDf515d1e7-5803-4797-b3cc-8dbea85d96e58
312941sertraline 50 MG Oral TabletSCD4cf8d5c8-842b-4e7c-9a99-3f41ef8abbdb8
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY4cf8d5c8-842b-4e7c-9a99-3f41ef8abbdb8
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY4cf8d5c8-842b-4e7c-9a99-3f41ef8abbdb8
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYf515d1e7-5803-4797-b3cc-8dbea85d96e58
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY4cf8d5c8-842b-4e7c-9a99-3f41ef8abbdb8
312938sertraline HCl 100 MG Oral TabletPSN10baaffd-061e-d665-e063-6294a90a15942
312940sertraline HCl 25 MG Oral TabletPSN3ee3a687-bbbf-4d17-8faf-33bc373282592
312940sertraline HCl 25 MG Oral TabletPSN10baaffd-061e-d665-e063-6294a90a15942
312941sertraline HCl 50 MG Oral TabletPSN10baaffd-061e-d665-e063-6294a90a15942
312938sertraline 100 MG Oral TabletSCD10baaffd-061e-d665-e063-6294a90a15942
312940sertraline 25 MG Oral TabletSCD10baaffd-061e-d665-e063-6294a90a15942
312940sertraline 25 MG Oral TabletSCD3ee3a687-bbbf-4d17-8faf-33bc373282592
312941sertraline 50 MG Oral TabletSCD10baaffd-061e-d665-e063-6294a90a15942
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY10baaffd-061e-d665-e063-6294a90a15942
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY10baaffd-061e-d665-e063-6294a90a15942
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY3ee3a687-bbbf-4d17-8faf-33bc373282592
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY10baaffd-061e-d665-e063-6294a90a15942

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-351-0168180035101100 TABLET, FILM COATED in 1 BOTTLE (68180-351-01) 2007-02-060000-00-00NoNoCurrent
68180-351-03681800351031000 TABLET, FILM COATED in 1 BOTTLE (68180-351-03) 2007-02-062028-03-31NoNoCurrent
68180-351-066818003510630 TABLET, FILM COATED in 1 BOTTLE (68180-351-06) 2007-02-062028-01-31NoNoCurrent
68180-351-086818003510850 TABLET, FILM COATED in 1 BOTTLE (68180-351-08) 2007-02-060000-00-00NoNoCurrent
68180-351-096818003510990 TABLET, FILM COATED in 1 BOTTLE (68180-351-09) 2007-02-062028-01-31NoNoCurrent