FDA.reportPublic FDA data

SERTRALINE HYDROCHLORIDE

Product NDC
31722-145
11-digit product format
317220145
Labeler code
31722
Product ID
31722-145_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
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
31722-145-05SERTRALINE HYDROCHLORIDE500 in 1 BOTTLETABLET5005
31722-145-30SERTRALINE HYDROCHLORIDE30 in 1 BOTTLETABLET305
31722-145-90SERTRALINE HYDROCHLORIDE90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-145-05EA - Each31722-145408a043b-50a5-4ba4-bc12-8e0e3289947f12021-08-05
31722-145-30EA - Each31722-1453e02b913-4528-4094-8c01-52492efe214212021-08-05
31722-145-90EA - Each31722-14533c8a007-2b64-41a8-9f61-c13c9e72be6212021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-145SERTRALINE 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
312940sertraline HCl 25 MG Oral TabletPSN48702ef4-21cd-754e-e063-6394a90af24e1
312940sertraline 25 MG Oral TabletSCD48702ef4-21cd-754e-e063-6394a90af24e1
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY48702ef4-21cd-754e-e063-6394a90af24e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-145-0531722014505500 TABLET in 1 BOTTLE (31722-145-05) 500 tablet2021-05-030000-00-00NoNoCurrent
31722-145-303172201453030 TABLET in 1 BOTTLE (31722-145-30) 30 tablet2021-05-030000-00-00NoNoCurrent
31722-145-903172201459090 TABLET in 1 BOTTLE (31722-145-90) 90 tablet2021-05-030000-00-00NoNoCurrent