FDA.reportPublic FDA data

Clarinex

Product NDC
50090-0765
11-digit product format
500900765
Labeler code
50090
Product ID
50090-0765_39a6d7f8-a5b1-4dbb-a1d2-ba8e9536ff48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desloratadine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA021165
Marketing category
NDA
Marketing start
2001-12-21
Marketing end
0000-00-00
Substance
DESLORATADINE
Active strength
5 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
01632a31-f1c5-44ea-aa59-efded68c0797Product name120150716
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
c6d3c427-3d3d-6bcf-7aa8-536d42cf1fd8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0765-02023-01-30C16284748780-1f386c649-b6dd-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CLARINEX safely and effectively. See full prescribing information for CLARINEX. CLARINEX ® (desloratadine) Tablets, RediTabs ® , and Oral Solution for oral use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0765-0Clarinex30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0765-0EA - Each50090-0765e649b574-7ec1-4fa0-9364-1eb10e29812012018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0765CLARINEX (DESLORATADINE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Legacy NDC, 1 package rows20210219_a7b5d043-da63-499c-b8bd-adf9295a6975.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
352086CLARINEX 5 MG Oral TabletPSNa7b5d043-da63-499c-b8bd-adf9295a69757
349420desloratadine 5 MG Oral TabletPSNa7b5d043-da63-499c-b8bd-adf9295a69757
352086desloratadine 5 MG Oral Tablet [Clarinex]SBDa7b5d043-da63-499c-b8bd-adf9295a69757
349420desloratadine 5 MG Oral TabletSCDa7b5d043-da63-499c-b8bd-adf9295a69757
352086Clarinex 5 MG Oral TabletSYa7b5d043-da63-499c-b8bd-adf9295a69757

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0765-05009007650030 TABLET, FILM COATED in 1 BOTTLE (50090-0765-0) 2014-11-280000-00-00NoNoCurrent