FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
68180-992
11-digit product format
681800992
Labeler code
68180
Product ID
68180-992_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
2025-08-06
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
68180-992-01Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3028
68180-992-02Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9028
68180-992-03Sertraline Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50028
68180-992-04Sertraline Hydrochloride5000 in 1 BOTTLETABLET, FILM COATED500028

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 TabletPSN473d6055-b811-4ffb-9398-88f50a1521969
312938sertraline HCl 100 MG Oral TabletPSN1b069fd8-26b9-459e-abfb-de28c012ddcb9
312938sertraline 100 MG Oral TabletSCD1b069fd8-26b9-459e-abfb-de28c012ddcb9
312938sertraline 100 MG Oral TabletSCD473d6055-b811-4ffb-9398-88f50a1521969
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY473d6055-b811-4ffb-9398-88f50a1521969
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY1b069fd8-26b9-459e-abfb-de28c012ddcb9
312938sertraline HCl 100 MG Oral TabletPSNfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312940sertraline HCl 25 MG Oral TabletPSNfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312941sertraline HCl 50 MG Oral TabletPSNfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312938sertraline 100 MG Oral TabletSCDfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312940sertraline 25 MG Oral TabletSCDfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312941sertraline 50 MG Oral TabletSCDfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYfd92c8d3-17ec-477c-bc25-e5239c8606ac2
312938sertraline HCl 100 MG Oral TabletPSNbdbcb3ce-e424-43eb-9f1a-77eda4dfbdaa1
312938sertraline HCl 100 MG Oral TabletPSNddbf623f-8b6f-4e8d-87d3-dc890c0ab8751
312938sertraline HCl 100 MG Oral TabletPSN40be43b2-649b-0928-e063-6394a90a3b481
312940sertraline HCl 25 MG Oral TabletPSN40be43b2-649b-0928-e063-6394a90a3b481
312941sertraline HCl 50 MG Oral TabletPSN40be43b2-649b-0928-e063-6394a90a3b481
312938sertraline 100 MG Oral TabletSCDddbf623f-8b6f-4e8d-87d3-dc890c0ab8751
312938sertraline 100 MG Oral TabletSCDbdbcb3ce-e424-43eb-9f1a-77eda4dfbdaa1
312938sertraline 100 MG Oral TabletSCD40be43b2-649b-0928-e063-6394a90a3b481
312940sertraline 25 MG Oral TabletSCD40be43b2-649b-0928-e063-6394a90a3b481
312941sertraline 50 MG Oral TabletSCD40be43b2-649b-0928-e063-6394a90a3b481
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYddbf623f-8b6f-4e8d-87d3-dc890c0ab8751
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYbdbcb3ce-e424-43eb-9f1a-77eda4dfbdaa1
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY40be43b2-649b-0928-e063-6394a90a3b481
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY40be43b2-649b-0928-e063-6394a90a3b481
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY40be43b2-649b-0928-e063-6394a90a3b481

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68180-992-016818009920130 TABLET, FILM COATED in 1 BOTTLE (68180-992-01) 2025-08-06NoNoCurrent
68180-992-026818009920290 TABLET, FILM COATED in 1 BOTTLE (68180-992-02) 2025-08-06NoNoCurrent
68180-992-0368180099203500 TABLET, FILM COATED in 1 BOTTLE (68180-992-03) 2025-08-06NoNoCurrent
68180-992-04681800992045000 TABLET, FILM COATED in 1 BOTTLE (68180-992-04) 2025-08-06NoNoCurrent