FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
16714-613
11-digit product format
167140613
Labeler code
16714
Product ID
16714-613_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
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
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-613-01Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3022
16714-613-02Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6022
16714-613-03Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9022
16714-613-04Sertraline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10022
16714-613-05Sertraline Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50022
16714-613-06Sertraline Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-613-01EA - Each16714-613a5a8820d-30b8-4de7-8798-378b9259aa9212012-07-24
16714-613-04EA - Each16714-613346cbd75-297d-4f64-94dc-ed278a732cc712012-07-24
16714-613-05EA - Each16714-6130da1b7e8-b71f-4027-9765-f708a9b0e7c212012-07-24
16714-613-06EA - Each16714-613bf277634-1eb1-4cd0-b214-daeb70aa92be12012-07-24

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
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSERTRALINE 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
16714-613SERTRALINE 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 TabletPSNc4bad433-623b-402c-b454-d39f19a2362729
312938sertraline 100 MG Oral TabletSCDc4bad433-623b-402c-b454-d39f19a2362729
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYc4bad433-623b-402c-b454-d39f19a2362729
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
312938sertraline HCl 100 MG Oral TabletPSNe815c67d-951c-4cb3-a840-f0b493b97da12
312938sertraline HCl 100 MG Oral TabletPSN86989ab1-9670-34b3-e053-2991aa0a07a92
312938sertraline 100 MG Oral TabletSCD86989ab1-9670-34b3-e053-2991aa0a07a92
312938sertraline 100 MG Oral TabletSCDe815c67d-951c-4cb3-a840-f0b493b97da12
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY86989ab1-9670-34b3-e053-2991aa0a07a92
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYe815c67d-951c-4cb3-a840-f0b493b97da12
312938sertraline HCl 100 MG Oral TabletPSNc3162f51-f3d1-4269-8d56-e56dc9da43fd1
312938sertraline HCl 100 MG Oral TabletPSN75a43476-25e0-44c3-bbab-2160041032d11
312938sertraline 100 MG Oral TabletSCDc3162f51-f3d1-4269-8d56-e56dc9da43fd1
312938sertraline 100 MG Oral TabletSCD75a43476-25e0-44c3-bbab-2160041032d11
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYc3162f51-f3d1-4269-8d56-e56dc9da43fd1
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY75a43476-25e0-44c3-bbab-2160041032d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-613-011671406130130 TABLET, FILM COATED in 1 BOTTLE (16714-613-01) 2007-02-060000-00-00NoNoCurrent
16714-613-021671406130260 TABLET, FILM COATED in 1 BOTTLE (16714-613-02) 2007-02-060000-00-00NoNoCurrent
16714-613-031671406130390 TABLET, FILM COATED in 1 BOTTLE (16714-613-03) 2007-02-060000-00-00NoNoCurrent
16714-613-0416714061304100 TABLET, FILM COATED in 1 BOTTLE (16714-613-04) 2007-02-060000-00-00NoNoCurrent
16714-613-0516714061305500 TABLET, FILM COATED in 1 BOTTLE (16714-613-05) 2007-02-060000-00-00NoNoCurrent
16714-613-06167140613061000 TABLET, FILM COATED in 1 BOTTLE (16714-613-06) 2007-02-060000-00-00NoNoCurrent