FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
43063-033
11-digit product format
430630033
Labeler code
43063
Product ID
43063-033_41364be7-cf7b-cab0-e063-6294a90a9346
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
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
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
43063-033-30Sertraline Hydrochloride30 in 1 BOTTLE, PLASTICTABLET3016
43063-033-60Sertraline Hydrochloride60 in 1 BOTTLE, PLASTICTABLET6016
43063-033-90Sertraline Hydrochloride90 in 1 BOTTLE, PLASTICTABLET9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-033-30EA - Each43063-0337ddf5c7f-c1a4-49e5-b16b-193aa1e5206a12017-08-11
43063-033-60EA - Each43063-033a57ab214-8462-4213-aa22-a55c6bcad2be12017-10-13
43063-033-90EA - Each43063-033d3d80066-73f5-42f8-ba13-4ccb0d0c986112017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-033SERTRALINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 3 package rows20240420_adfcc867-1b6e-4698-94b6-2b4190c4ba3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312941sertraline HCl 50 MG Oral TabletPSNadfcc867-1b6e-4698-94b6-2b4190c4ba3d16
312941sertraline 50 MG Oral TabletSCDadfcc867-1b6e-4698-94b6-2b4190c4ba3d16
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYadfcc867-1b6e-4698-94b6-2b4190c4ba3d16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-033-304306300333030 TABLET in 1 BOTTLE, PLASTIC (43063-033-30) 30 tablet2017-06-270000-00-00NoNoCurrent
43063-033-604306300336060 TABLET in 1 BOTTLE, PLASTIC (43063-033-60) 60 tablet2017-09-120000-00-00NoNoCurrent
43063-033-904306300339090 TABLET in 1 BOTTLE, PLASTIC (43063-033-90) 90 tablet2017-04-140000-00-00NoNoCurrent