FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
68180-353
11-digit product format
681800353
Labeler code
68180
Product ID
68180-353_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
100 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 HYDROCHLORIDE100 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
68180-353-01Sertraline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10028
68180-353-02Sertraline Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50028
68180-353-03Sertraline Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100028
68180-353-05Sertraline Hydrochloride5000 in 1 BOTTLETABLET, FILM COATED500028
68180-353-06Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3028
68180-353-09Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9028
68180-353-11Sertraline Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED1028
68180-353-11Sertraline Hydrochloride10 in 1 CARTONTABLET, FILM COATED1028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-353-02EA - Each68180-35329f7ba90-500a-4d88-87ca-725ea1b83c3a12012-07-24
68180-353-05EA - Each68180-3534ad23fbf-d041-4d41-b2dd-26b9713ae9f612012-07-24
68180-353-06EA - Each68180-35352b9ddb1-3b3d-44cb-8eca-1b2cd3b2b07412012-07-24
68180-353-09EA - Each68180-35392933bb2-1a87-40b4-903b-d6949278953c12012-07-24

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 [AIDAREX PHARMACEUTICALS LLC]1
SERTRALINEACTIVE MOIETYQUC7NX6WMBSERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-353SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]24Current NDC, Legacy NDC, 8 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
312938sertraline HCl 100 MG Oral TabletPSNe1864a7e-44b9-4399-9554-0c18b46fbdd614
312938sertraline 100 MG Oral TabletSCDe1864a7e-44b9-4399-9554-0c18b46fbdd614
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYe1864a7e-44b9-4399-9554-0c18b46fbdd614
312938sertraline HCl 100 MG Oral TabletPSNb2533b60-cc54-4905-a4ee-ea08a160f8c610
312938sertraline 100 MG Oral TabletSCDb2533b60-cc54-4905-a4ee-ea08a160f8c610
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYb2533b60-cc54-4905-a4ee-ea08a160f8c610
312938sertraline HCl 100 MG Oral TabletPSNf5bf9595-d9f9-40b1-9b3b-da277fd5ab7f9
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 TabletSCDf5bf9595-d9f9-40b1-9b3b-da277fd5ab7f9
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
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYf5bf9595-d9f9-40b1-9b3b-da277fd5ab7f9
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
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
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
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY4cf8d5c8-842b-4e7c-9a99-3f41ef8abbdb8
312938sertraline HCl 100 MG Oral TabletPSN10baaffd-061e-d665-e063-6294a90a15942
312938sertraline HCl 100 MG Oral TabletPSN597bab7a-3ba0-1083-e053-2a91aa0a9d482
312938sertraline HCl 100 MG Oral TabletPSN0a1f7d44-c339-a4dd-e063-6294a90ac0de2
312940sertraline HCl 25 MG Oral TabletPSN10baaffd-061e-d665-e063-6294a90a15942
312941sertraline HCl 50 MG Oral TabletPSN10baaffd-061e-d665-e063-6294a90a15942
312938sertraline 100 MG Oral TabletSCD597bab7a-3ba0-1083-e053-2a91aa0a9d482
312938sertraline 100 MG Oral TabletSCD0a1f7d44-c339-a4dd-e063-6294a90ac0de2
312938sertraline 100 MG Oral TabletSCD10baaffd-061e-d665-e063-6294a90a15942
312940sertraline 25 MG Oral TabletSCD10baaffd-061e-d665-e063-6294a90a15942
312941sertraline 50 MG Oral TabletSCD10baaffd-061e-d665-e063-6294a90a15942
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY0a1f7d44-c339-a4dd-e063-6294a90ac0de2
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY10baaffd-061e-d665-e063-6294a90a15942
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY597bab7a-3ba0-1083-e053-2a91aa0a9d482
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY10baaffd-061e-d665-e063-6294a90a15942
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY10baaffd-061e-d665-e063-6294a90a15942
312938sertraline HCl 100 MG Oral TabletPSN9b121d06-8de7-4c63-8000-19edc2861b9b1
312938sertraline 100 MG Oral TabletSCD9b121d06-8de7-4c63-8000-19edc2861b9b1
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY9b121d06-8de7-4c63-8000-19edc2861b9b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-353-0168180035301100 TABLET, FILM COATED in 1 BOTTLE (68180-353-01) 2007-02-060000-00-00NoNoCurrent
68180-353-0268180035302500 TABLET, FILM COATED in 1 BOTTLE (68180-353-02) 2007-02-062028-05-31NoNoCurrent
68180-353-03681800353031000 TABLET, FILM COATED in 1 BOTTLE (68180-353-03) 2007-02-060000-00-00NoNoCurrent
68180-353-05681800353055000 TABLET, FILM COATED in 1 BOTTLE (68180-353-05) 2007-02-062027-05-31NoNoCurrent
68180-353-066818003530630 TABLET, FILM COATED in 1 BOTTLE (68180-353-06) 2007-02-062028-02-29NoNoCurrent
68180-353-096818003530990 TABLET, FILM COATED in 1 BOTTLE (68180-353-09) 2007-02-062028-04-30NoNoCurrent
68180-353-116818003531110 BLISTER PACK in 1 CARTON (68180-353-11) > 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2007-02-060000-00-00NoNoCurrent