FDA.reportPublic FDA data

SERTRALINE HYDROCHLORIDE

Product NDC
31722-146
11-digit product format
317220146
Labeler code
31722
Product ID
31722-146_174443f7-0f33-47d5-89cd-fce503ec8f36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sertraline hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA214790
Marketing category
ANDA
Marketing start
2021-05-03
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
31722-146-05SERTRALINE HYDROCHLORIDE500 in 1 BOTTLETABLET5005
31722-146-30SERTRALINE HYDROCHLORIDE30 in 1 BOTTLETABLET305
31722-146-90SERTRALINE HYDROCHLORIDE90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-146-05EA - Each31722-14632cc23da-8b4f-4ca4-87df-d474d947bc3012021-08-05
31722-146-30EA - Each31722-146c577ae91-b490-446d-80c4-8ed6aee048fa12021-08-05
31722-146-90EA - Each31722-146d292ce91-0fd8-4d4d-8fb5-38e131cddce012021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-146SERTRALINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 3 package rows20241012_de1f85ac-df1b-4b7b-8e18-48ebdc8b9279.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSNde1f85ac-df1b-4b7b-8e18-48ebdc8b92795
312940sertraline HCl 25 MG Oral TabletPSNde1f85ac-df1b-4b7b-8e18-48ebdc8b92795
312941sertraline HCl 50 MG Oral TabletPSNde1f85ac-df1b-4b7b-8e18-48ebdc8b92795
312938sertraline 100 MG Oral TabletSCDde1f85ac-df1b-4b7b-8e18-48ebdc8b92795
312940sertraline 25 MG Oral TabletSCDde1f85ac-df1b-4b7b-8e18-48ebdc8b92795
312941sertraline 50 MG Oral TabletSCDde1f85ac-df1b-4b7b-8e18-48ebdc8b92795
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYde1f85ac-df1b-4b7b-8e18-48ebdc8b92795
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYde1f85ac-df1b-4b7b-8e18-48ebdc8b92795
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYde1f85ac-df1b-4b7b-8e18-48ebdc8b92795
312941sertraline HCl 50 MG Oral TabletPSN2bb3a2d1-76c4-42e6-8553-aa95f263175b1
312941sertraline HCl 50 MG Oral TabletPSN50b54bfa-0b90-44f1-8f73-4f7f552449c41
312941sertraline 50 MG Oral TabletSCD2bb3a2d1-76c4-42e6-8553-aa95f263175b1
312941sertraline 50 MG Oral TabletSCD50b54bfa-0b90-44f1-8f73-4f7f552449c41
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY2bb3a2d1-76c4-42e6-8553-aa95f263175b1
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY50b54bfa-0b90-44f1-8f73-4f7f552449c41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-146-0531722014605500 TABLET in 1 BOTTLE (31722-146-05) 500 tablet2021-05-030000-00-00NoNoCurrent
31722-146-303172201463030 TABLET in 1 BOTTLE (31722-146-30) 30 tablet2021-05-030000-00-00NoNoCurrent
31722-146-903172201469090 TABLET in 1 BOTTLE (31722-146-90) 90 tablet2021-05-030000-00-00NoNoCurrent