FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
65862-011
11-digit product format
658620011
Labeler code
65862
Product ID
65862-011_50d67885-52a9-49a4-9f2a-f82749747222
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA077206
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
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-011-01Sertraline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10030
65862-011-05Sertraline Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50030
65862-011-30Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3030
65862-011-50Sertraline Hydrochloride50 in 1 BOTTLETABLET, FILM COATED5030
65862-011-51Sertraline Hydrochloride5000 in 1 BOTTLETABLET, FILM COATED500030
65862-011-60Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6030
65862-011-90Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9030
65862-011-99Sertraline Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-011-01EA - Each65862-0111e7bb4a8-d241-4036-bfb2-51d59c4c6fd912012-07-24
65862-011-05EA - Each65862-0119449c2ef-0eee-48fd-a99c-1088c72edc7c12012-07-24
65862-011-30EA - Each65862-01198d86e4d-14b7-4d3e-9381-8eea7a08a76212012-07-24
65862-011-90EA - Each65862-011036d62be-4035-466e-9753-6fdf3187579612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SERTRALINE HYDROCHLORIDEACTIVE INGREDIENTUTI8907Y6XSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
SERTRALINEACTIVE MOIETYQUC7NX6WMBSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-011SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]30Current NDC, Legacy NDC, 8 package rows20240210_39a85db1-9e59-4ab0-9e18-36757f019faa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312940sertraline HCl 25 MG Oral TabletPSN5c6c817e-a555-4f55-837d-94458787fcb6102
312940sertraline 25 MG Oral TabletSCD5c6c817e-a555-4f55-837d-94458787fcb6102
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY5c6c817e-a555-4f55-837d-94458787fcb6102
312938sertraline HCl 100 MG Oral TabletPSN286b429d-62b9-4ca8-a243-de3f619315bf37
312940sertraline HCl 25 MG Oral TabletPSN286b429d-62b9-4ca8-a243-de3f619315bf37
312941sertraline HCl 50 MG Oral TabletPSN286b429d-62b9-4ca8-a243-de3f619315bf37
312938sertraline 100 MG Oral TabletSCD286b429d-62b9-4ca8-a243-de3f619315bf37
312940sertraline 25 MG Oral TabletSCD286b429d-62b9-4ca8-a243-de3f619315bf37
312941sertraline 50 MG Oral TabletSCD286b429d-62b9-4ca8-a243-de3f619315bf37
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY286b429d-62b9-4ca8-a243-de3f619315bf37
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY286b429d-62b9-4ca8-a243-de3f619315bf37
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY286b429d-62b9-4ca8-a243-de3f619315bf37
312940sertraline HCl 25 MG Oral TabletPSN0e5a7b02-3972-47f0-9f49-e958d792beac32
312940sertraline 25 MG Oral TabletSCD0e5a7b02-3972-47f0-9f49-e958d792beac32
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY0e5a7b02-3972-47f0-9f49-e958d792beac32
312938sertraline HCl 100 MG Oral TabletPSN39a85db1-9e59-4ab0-9e18-36757f019faa30
312940sertraline HCl 25 MG Oral TabletPSN39a85db1-9e59-4ab0-9e18-36757f019faa30
312941sertraline HCl 50 MG Oral TabletPSN39a85db1-9e59-4ab0-9e18-36757f019faa30
312938sertraline 100 MG Oral TabletSCD39a85db1-9e59-4ab0-9e18-36757f019faa30
312940sertraline 25 MG Oral TabletSCD39a85db1-9e59-4ab0-9e18-36757f019faa30
312941sertraline 50 MG Oral TabletSCD39a85db1-9e59-4ab0-9e18-36757f019faa30
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY39a85db1-9e59-4ab0-9e18-36757f019faa30
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY39a85db1-9e59-4ab0-9e18-36757f019faa30
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY39a85db1-9e59-4ab0-9e18-36757f019faa30
312940sertraline HCl 25 MG Oral TabletPSN575da603-b038-421f-9894-6796d9ac33cc15
312940sertraline 25 MG Oral TabletSCD575da603-b038-421f-9894-6796d9ac33cc15
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY575da603-b038-421f-9894-6796d9ac33cc15
312940sertraline HCl 25 MG Oral TabletPSNb559c20d-70be-41e7-acfb-262ffc3ea8789
312940sertraline 25 MG Oral TabletSCDb559c20d-70be-41e7-acfb-262ffc3ea8789
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYb559c20d-70be-41e7-acfb-262ffc3ea8789
312940sertraline HCl 25 MG Oral TabletPSN6dd71a5b-1923-54fb-e053-2991aa0a619e5
312940sertraline 25 MG Oral TabletSCD6dd71a5b-1923-54fb-e053-2991aa0a619e5
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY6dd71a5b-1923-54fb-e053-2991aa0a619e5
312938sertraline HCl 100 MG Oral TabletPSN06c47a1b-e41a-457d-8a4f-863cece11d1c4
312940sertraline HCl 25 MG Oral TabletPSN06c47a1b-e41a-457d-8a4f-863cece11d1c4
312941sertraline HCl 50 MG Oral TabletPSN06c47a1b-e41a-457d-8a4f-863cece11d1c4
312938sertraline 100 MG Oral TabletSCD06c47a1b-e41a-457d-8a4f-863cece11d1c4
312940sertraline 25 MG Oral TabletSCD06c47a1b-e41a-457d-8a4f-863cece11d1c4
312941sertraline 50 MG Oral TabletSCD06c47a1b-e41a-457d-8a4f-863cece11d1c4
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY06c47a1b-e41a-457d-8a4f-863cece11d1c4
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY06c47a1b-e41a-457d-8a4f-863cece11d1c4
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY06c47a1b-e41a-457d-8a4f-863cece11d1c4
312940sertraline HCl 25 MG Oral TabletPSNb6f306d9-009e-438e-9672-d9f359e4d0da3
312940sertraline 25 MG Oral TabletSCDb6f306d9-009e-438e-9672-d9f359e4d0da3
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYb6f306d9-009e-438e-9672-d9f359e4d0da3
312938sertraline HCl 100 MG Oral TabletPSNe25a13c3-a173-4cc3-99d3-0be43abbc4982
312940sertraline HCl 25 MG Oral TabletPSNe25a13c3-a173-4cc3-99d3-0be43abbc4982
312940sertraline HCl 25 MG Oral TabletPSNbc1abb84-4160-1aee-e053-2995a90af27c2
312940sertraline HCl 25 MG Oral TabletPSNba201164-f6f7-4779-87a3-62780f3321132
312941sertraline HCl 50 MG Oral TabletPSNe25a13c3-a173-4cc3-99d3-0be43abbc4982
312938sertraline 100 MG Oral TabletSCDe25a13c3-a173-4cc3-99d3-0be43abbc4982
312940sertraline 25 MG Oral TabletSCDba201164-f6f7-4779-87a3-62780f3321132
312940sertraline 25 MG Oral TabletSCDbc1abb84-4160-1aee-e053-2995a90af27c2
312940sertraline 25 MG Oral TabletSCDe25a13c3-a173-4cc3-99d3-0be43abbc4982
312941sertraline 50 MG Oral TabletSCDe25a13c3-a173-4cc3-99d3-0be43abbc4982
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYe25a13c3-a173-4cc3-99d3-0be43abbc4982
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYbc1abb84-4160-1aee-e053-2995a90af27c2
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYe25a13c3-a173-4cc3-99d3-0be43abbc4982
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYba201164-f6f7-4779-87a3-62780f3321132
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYe25a13c3-a173-4cc3-99d3-0be43abbc4982
312940sertraline HCl 25 MG Oral TabletPSN8f5a71b2-2821-46a0-ac65-28d9b2db73ec1
312940sertraline 25 MG Oral TabletSCD8f5a71b2-2821-46a0-ac65-28d9b2db73ec1
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY8f5a71b2-2821-46a0-ac65-28d9b2db73ec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-011-0165862001101100 TABLET, FILM COATED in 1 BOTTLE (65862-011-01) 2007-02-060000-00-00NoNoCurrent
65862-011-0565862001105500 TABLET, FILM COATED in 1 BOTTLE (65862-011-05) 2007-02-060000-00-00NoNoCurrent
65862-011-306586200113030 TABLET, FILM COATED in 1 BOTTLE (65862-011-30) 2007-02-060000-00-00NoNoCurrent
65862-011-506586200115050 TABLET, FILM COATED in 1 BOTTLE (65862-011-50) 2007-02-060000-00-00NoNoCurrent
65862-011-51658620011515000 TABLET, FILM COATED in 1 BOTTLE (65862-011-51) 2007-02-060000-00-00NoNoCurrent
65862-011-606586200116060 TABLET, FILM COATED in 1 BOTTLE (65862-011-60) 2007-02-060000-00-00NoNoCurrent
65862-011-906586200119090 TABLET, FILM COATED in 1 BOTTLE (65862-011-90) 2007-02-060000-00-00NoNoCurrent
65862-011-99658620011991000 TABLET, FILM COATED in 1 BOTTLE (65862-011-99) 2007-02-060000-00-00NoNoCurrent