FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
0904-6926
11-digit product format
009046926
Labeler code
0904
Product ID
0904-6926_e586e0c5-ace8-4575-a549-f4c85a351653
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
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
2026-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6926-61Sertraline Hydrochloride100 in 1 CARTONTABLET, FILM COATED1008
0904-6926-61Sertraline Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6926-61EA - Each0904-692603b1a6e8-e4c1-4011-ad8a-72cc45819a8b12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6926SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]6Current NDC, Legacy NDC, 2 package rows20250509_4cf8d5c8-842b-4e7c-9a99-3f41ef8abbdb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 TabletPSNfd8a815e-88b7-4bef-9e32-6dbc735711a36
312941sertraline HCl 50 MG Oral TabletPSNfd8a815e-88b7-4bef-9e32-6dbc735711a36
312938sertraline 100 MG Oral TabletSCDfd8a815e-88b7-4bef-9e32-6dbc735711a36
312941sertraline 50 MG Oral TabletSCDfd8a815e-88b7-4bef-9e32-6dbc735711a36
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYfd8a815e-88b7-4bef-9e32-6dbc735711a36
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYfd8a815e-88b7-4bef-9e32-6dbc735711a36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6926-6100904692661100 BLISTER PACK in 1 CARTON (0904-6926-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2007-02-060000-00-00NoNoCurrent