FDA.reportPublic FDA data

SERTRALINE HYDROCHLORIDE

Product NDC
43063-855
11-digit product format
430630855
Labeler code
43063
Product ID
43063-855_525b23be-4bed-f30f-e063-6294a90a1773
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SERTRALINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA202825
Marketing category
ANDA
Marketing start
2017-02-09
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
2027-12-31
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 HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUTI8907Y6X
Rxcui312941

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
43063-855-30SERTRALINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3021
43063-855-60SERTRALINE HYDROCHLORIDE60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6021
43063-855-90SERTRALINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-855-30EA - Each43063-85505d84fe7-4a71-4bf9-8e42-47b3b616c27e12018-08-13
43063-855-60EA - Each43063-855e99266be-1df5-4de3-ae74-526e7c71f02412018-08-13
43063-855-90EA - Each43063-8553bee4ed9-df40-4a3c-a091-cc56e1e40c6312018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-855SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]19Current NDC, Legacy NDC, 3 package rows20240704_aa13261f-46a7-4381-8084-b3ad46221e2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312941sertraline HCl 50 MG Oral TabletPSNaa13261f-46a7-4381-8084-b3ad46221e2f21
312941sertraline 50 MG Oral TabletSCDaa13261f-46a7-4381-8084-b3ad46221e2f21
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYaa13261f-46a7-4381-8084-b3ad46221e2f21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-855-304306308553030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-855-30) 2018-07-090000-00-00NoNoCurrent
43063-855-604306308556060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-855-60) 2018-07-090000-00-00NoNoCurrent
43063-855-904306308559090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-855-90) 2018-05-290000-00-00NoNoCurrent