FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
43063-754
11-digit product format
430630754
Labeler code
43063
Product ID
43063-754_414b7ce2-754f-5e40-e063-6294a90afda2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA077397
Marketing category
ANDA
Marketing start
2016-07-21
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SERTRALINE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUTI8907Y6X
Rxcui312938

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
43063-754-30Sertraline Hydrochloride30 in 1 BOTTLE, PLASTICTABLET3017
43063-754-60Sertraline Hydrochloride60 in 1 BOTTLE, PLASTICTABLET6017
43063-754-90Sertraline Hydrochloride90 in 1 BOTTLE, PLASTICTABLET9017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-754-30EA - Each43063-7548957d391-b734-40da-be33-000d7a2ac98e12017-07-07
43063-754-60EA - Each43063-75492944f84-ba3c-49ff-b693-7d820a4f6fbd12017-09-11
43063-754-90EA - Each43063-754bd4477b2-1e0d-4eaa-b451-9bcbf40d6f6c12017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-754SERTRALINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]16Current NDC, Legacy NDC, 3 package rows20240608_52c88667-c67e-4d42-b319-afb354713b1e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN52c88667-c67e-4d42-b319-afb354713b1e17
312938sertraline 100 MG Oral TabletSCD52c88667-c67e-4d42-b319-afb354713b1e17
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY52c88667-c67e-4d42-b319-afb354713b1e17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-754-304306307543030 TABLET in 1 BOTTLE, PLASTIC (43063-754-30) 30 tablet2017-06-090000-00-00NoNoCurrent
43063-754-604306307546060 TABLET in 1 BOTTLE, PLASTIC (43063-754-60) 60 tablet2017-07-310000-00-00NoNoCurrent
43063-754-904306307549090 TABLET in 1 BOTTLE, PLASTIC (43063-754-90) 90 tablet2017-04-170000-00-00NoNoCurrent