FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
16714-612
11-digit product format
167140612
Labeler code
16714
Product ID
16714-612_8e670c10-d58c-4b50-96b6-9a67331a29c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA077206
Marketing category
ANDA
Marketing start
2007-02-06
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
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
16714-612-01Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3022
16714-612-02Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6022
16714-612-03Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9022
16714-612-04Sertraline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10022
16714-612-05Sertraline Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50022
16714-612-06Sertraline Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-612-01EA - Each16714-61231684c2d-f5e1-48ba-9fe0-d07139ec86a612012-07-24
16714-612-04EA - Each16714-6128c39f9fe-8248-49de-bd94-c5156bab521512012-07-24
16714-612-05EA - Each16714-612d73f9373-b657-4866-998e-06c154c4bd0312012-07-24
16714-612-06EA - Each16714-61273791dd4-d77d-43b4-ad5d-2b57d79d801f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SERTRALINE HYDROCHLORIDEACTIVE INGREDIENTUTI8907Y6XSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]7
SERTRALINEACTIVE MOIETYQUC7NX6WMBSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]7
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]7
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]7
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]7
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]7
SERTRALINE HYDROCHLORIDEACTIVE INGREDIENTUTI8907Y6XSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
SERTRALINEACTIVE MOIETYQUC7NX6WMBSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-612SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]22Current NDC, Legacy NDC, 6 package rows20240210_9bc362d4-489c-4e7f-915a-3076ff8d132a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN9bc362d4-489c-4e7f-915a-3076ff8d132a22
312940sertraline HCl 25 MG Oral TabletPSN9bc362d4-489c-4e7f-915a-3076ff8d132a22
312941sertraline HCl 50 MG Oral TabletPSN9bc362d4-489c-4e7f-915a-3076ff8d132a22
312938sertraline 100 MG Oral TabletSCD9bc362d4-489c-4e7f-915a-3076ff8d132a22
312940sertraline 25 MG Oral TabletSCD9bc362d4-489c-4e7f-915a-3076ff8d132a22
312941sertraline 50 MG Oral TabletSCD9bc362d4-489c-4e7f-915a-3076ff8d132a22
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY9bc362d4-489c-4e7f-915a-3076ff8d132a22
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY9bc362d4-489c-4e7f-915a-3076ff8d132a22
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY9bc362d4-489c-4e7f-915a-3076ff8d132a22
312941sertraline HCl 50 MG Oral TabletPSNaf4aa590-d101-7917-e053-2a95a90a9a833
312941sertraline 50 MG Oral TabletSCDaf4aa590-d101-7917-e053-2a95a90a9a833
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYaf4aa590-d101-7917-e053-2a95a90a9a833
312941sertraline HCl 50 MG Oral TabletPSNe1ab6b63-27c1-3bfa-e053-2995a90af20a1
312941sertraline HCl 50 MG Oral TabletPSN626a9271-a268-4194-935d-779377f902f51
312941sertraline HCl 50 MG Oral TabletPSN513ecb5b-062f-455f-b798-1c9a54222ff31
312941sertraline HCl 50 MG Oral TabletPSN478b6915-9d73-4681-bee0-0f4540fd48391
312941sertraline 50 MG Oral TabletSCD626a9271-a268-4194-935d-779377f902f51
312941sertraline 50 MG Oral TabletSCD513ecb5b-062f-455f-b798-1c9a54222ff31
312941sertraline 50 MG Oral TabletSCDe1ab6b63-27c1-3bfa-e053-2995a90af20a1
312941sertraline 50 MG Oral TabletSCD478b6915-9d73-4681-bee0-0f4540fd48391
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYe1ab6b63-27c1-3bfa-e053-2995a90af20a1
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY626a9271-a268-4194-935d-779377f902f51
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY513ecb5b-062f-455f-b798-1c9a54222ff31
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY478b6915-9d73-4681-bee0-0f4540fd48391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-612-011671406120130 TABLET, FILM COATED in 1 BOTTLE (16714-612-01) 2007-02-060000-00-00NoNoCurrent
16714-612-021671406120260 TABLET, FILM COATED in 1 BOTTLE (16714-612-02) 2007-02-060000-00-00NoNoCurrent
16714-612-031671406120390 TABLET, FILM COATED in 1 BOTTLE (16714-612-03) 2007-02-060000-00-00NoNoCurrent
16714-612-0416714061204100 TABLET, FILM COATED in 1 BOTTLE (16714-612-04) 2007-02-060000-00-00NoNoCurrent
16714-612-0516714061205500 TABLET, FILM COATED in 1 BOTTLE (16714-612-05) 2007-02-060000-00-00NoNoCurrent
16714-612-06167140612061000 TABLET, FILM COATED in 1 BOTTLE (16714-612-06) 2007-02-060000-00-00NoNoCurrent