FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
69097-834
11-digit product format
690970834
Labeler code
69097
Product ID
69097-834_a0c9adca-e44e-4454-8eb5-7dc56b0b73b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA077397
Marketing category
ANDA
Marketing start
2016-07-21
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
69097-834-02Sertraline Hydrochloride30 in 1 BOTTLETABLET3010
69097-834-05Sertraline Hydrochloride90 in 1 BOTTLETABLET9010
69097-834-07Sertraline Hydrochloride100 in 1 BOTTLETABLET10010
69097-834-12Sertraline Hydrochloride500 in 1 BOTTLETABLET50010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-834SERTRALINE HYDROCHLORIDE TABLET [CIPLA USA INC.]10Current NDC, Legacy NDC, 4 package rows20240310_cf71d1b9-5ebb-429f-a07f-a87cd168250f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN44d9d754-f4da-4792-9e23-93faad0bffd122
312940sertraline HCl 25 MG Oral TabletPSN44d9d754-f4da-4792-9e23-93faad0bffd122
312941sertraline HCl 50 MG Oral TabletPSN44d9d754-f4da-4792-9e23-93faad0bffd122
312938sertraline 100 MG Oral TabletSCD44d9d754-f4da-4792-9e23-93faad0bffd122
312940sertraline 25 MG Oral TabletSCD44d9d754-f4da-4792-9e23-93faad0bffd122
312941sertraline 50 MG Oral TabletSCD44d9d754-f4da-4792-9e23-93faad0bffd122
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY44d9d754-f4da-4792-9e23-93faad0bffd122
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY44d9d754-f4da-4792-9e23-93faad0bffd122
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY44d9d754-f4da-4792-9e23-93faad0bffd122
312938sertraline HCl 100 MG Oral TabletPSNbd86b293-dab9-4d37-95eb-2bffca335d1616
312940sertraline HCl 25 MG Oral TabletPSNbd86b293-dab9-4d37-95eb-2bffca335d1616
312941sertraline HCl 50 MG Oral TabletPSNadfcc867-1b6e-4698-94b6-2b4190c4ba3d16
312941sertraline HCl 50 MG Oral TabletPSNbd86b293-dab9-4d37-95eb-2bffca335d1616
312938sertraline 100 MG Oral TabletSCDbd86b293-dab9-4d37-95eb-2bffca335d1616
312940sertraline 25 MG Oral TabletSCDbd86b293-dab9-4d37-95eb-2bffca335d1616
312941sertraline 50 MG Oral TabletSCDbd86b293-dab9-4d37-95eb-2bffca335d1616
312941sertraline 50 MG Oral TabletSCDadfcc867-1b6e-4698-94b6-2b4190c4ba3d16
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYbd86b293-dab9-4d37-95eb-2bffca335d1616
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYbd86b293-dab9-4d37-95eb-2bffca335d1616
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYadfcc867-1b6e-4698-94b6-2b4190c4ba3d16
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYbd86b293-dab9-4d37-95eb-2bffca335d1616
312938sertraline HCl 100 MG Oral TabletPSNcf71d1b9-5ebb-429f-a07f-a87cd168250f10
312938sertraline HCl 100 MG Oral TabletPSNd8102ff3-2b91-461d-9b99-f73443d8578d10
312940sertraline HCl 25 MG Oral TabletPSNd8102ff3-2b91-461d-9b99-f73443d8578d10
312940sertraline HCl 25 MG Oral TabletPSNcf71d1b9-5ebb-429f-a07f-a87cd168250f10
312941sertraline HCl 50 MG Oral TabletPSNd8102ff3-2b91-461d-9b99-f73443d8578d10
312941sertraline HCl 50 MG Oral TabletPSNcf71d1b9-5ebb-429f-a07f-a87cd168250f10
312938sertraline 100 MG Oral TabletSCDd8102ff3-2b91-461d-9b99-f73443d8578d10
312938sertraline 100 MG Oral TabletSCDcf71d1b9-5ebb-429f-a07f-a87cd168250f10
312940sertraline 25 MG Oral TabletSCDcf71d1b9-5ebb-429f-a07f-a87cd168250f10
312940sertraline 25 MG Oral TabletSCDd8102ff3-2b91-461d-9b99-f73443d8578d10
312941sertraline 50 MG Oral TabletSCDcf71d1b9-5ebb-429f-a07f-a87cd168250f10
312941sertraline 50 MG Oral TabletSCDd8102ff3-2b91-461d-9b99-f73443d8578d10
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYd8102ff3-2b91-461d-9b99-f73443d8578d10
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYcf71d1b9-5ebb-429f-a07f-a87cd168250f10
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYd8102ff3-2b91-461d-9b99-f73443d8578d10
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYcf71d1b9-5ebb-429f-a07f-a87cd168250f10
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYd8102ff3-2b91-461d-9b99-f73443d8578d10
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYcf71d1b9-5ebb-429f-a07f-a87cd168250f10
312938sertraline HCl 100 MG Oral TabletPSN4e09f580-d612-416c-a4a4-79a4411845b27
312940sertraline HCl 25 MG Oral TabletPSN4e09f580-d612-416c-a4a4-79a4411845b27
312941sertraline HCl 50 MG Oral TabletPSN4e09f580-d612-416c-a4a4-79a4411845b27
312938sertraline 100 MG Oral TabletSCD4e09f580-d612-416c-a4a4-79a4411845b27
312940sertraline 25 MG Oral TabletSCD4e09f580-d612-416c-a4a4-79a4411845b27
312941sertraline 50 MG Oral TabletSCD4e09f580-d612-416c-a4a4-79a4411845b27
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY4e09f580-d612-416c-a4a4-79a4411845b27
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY4e09f580-d612-416c-a4a4-79a4411845b27
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY4e09f580-d612-416c-a4a4-79a4411845b27
312938sertraline HCl 100 MG Oral TabletPSN2ff82f14-5035-4716-9372-ebc496cd34ec4
312941sertraline HCl 50 MG Oral TabletPSN2ff82f14-5035-4716-9372-ebc496cd34ec4
312938sertraline 100 MG Oral TabletSCD2ff82f14-5035-4716-9372-ebc496cd34ec4
312941sertraline 50 MG Oral TabletSCD2ff82f14-5035-4716-9372-ebc496cd34ec4
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY2ff82f14-5035-4716-9372-ebc496cd34ec4
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY2ff82f14-5035-4716-9372-ebc496cd34ec4
312941sertraline HCl 50 MG Oral TabletPSN551d5946-00df-4608-96a2-b29f0ef93ba03
312941sertraline HCl 50 MG Oral TabletPSN549afcf3-69c3-396c-e054-00144ff8d46c3
312941sertraline HCl 50 MG Oral TabletPSN2f7dea8d-9af7-4e56-a57a-8b6f812062193
312941sertraline 50 MG Oral TabletSCD551d5946-00df-4608-96a2-b29f0ef93ba03
312941sertraline 50 MG Oral TabletSCD549afcf3-69c3-396c-e054-00144ff8d46c3
312941sertraline 50 MG Oral TabletSCD2f7dea8d-9af7-4e56-a57a-8b6f812062193
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY2f7dea8d-9af7-4e56-a57a-8b6f812062193
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY551d5946-00df-4608-96a2-b29f0ef93ba03
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY549afcf3-69c3-396c-e054-00144ff8d46c3
312941sertraline HCl 50 MG Oral TabletPSN59287bc1-ac6f-47d2-84ba-b52f32f5894f1
312941sertraline 50 MG Oral TabletSCD59287bc1-ac6f-47d2-84ba-b52f32f5894f1
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY59287bc1-ac6f-47d2-84ba-b52f32f5894f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-834-026909708340230 TABLET in 1 BOTTLE (69097-834-02) 30 tablet2016-07-210000-00-00NoNoCurrent
69097-834-056909708340590 TABLET in 1 BOTTLE (69097-834-05) 90 tablet2016-07-210000-00-00NoNoCurrent
69097-834-0769097083407100 TABLET in 1 BOTTLE (69097-834-07) 100 tablet2016-07-210000-00-00NoNoCurrent
69097-834-1269097083412500 TABLET in 1 BOTTLE (69097-834-12) 500 tablet2016-07-210000-00-00NoNoCurrent