Clarinex

Product NDC
78206-119
11-digit product format
782060119
Labeler code
78206
Product ID
78206-119_6ec783d3-9308-4f6b-bfda-b41888b95102
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desloratadine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Organon LLC
Application
NDA021165
Marketing category
NDA
Marketing start
2021-06-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clarinex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESLORATADINE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFVF865388R
Rxcui349420, 352086

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78206-119-01Clarinex100 in 1 BOTTLETABLET, FILM COATED1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-119-01EA - Each78206-119fb296974-70ba-4f1d-aff5-131f7670508912021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-119CLARINEX (DESLORATADINE) TABLET, FILM COATED [ORGANON LLC]6Current NDC, Legacy NDC, 1 package rows20250528_c671342e-69a2-4ca5-abc2-8166ed4240d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
352086CLARINEX 5 MG Oral TabletPSNc671342e-69a2-4ca5-abc2-8166ed4240d46
349420desloratadine 5 MG Oral TabletPSNc671342e-69a2-4ca5-abc2-8166ed4240d46
352086desloratadine 5 MG Oral Tablet [Clarinex]SBDc671342e-69a2-4ca5-abc2-8166ed4240d46
349420desloratadine 5 MG Oral TabletSCDc671342e-69a2-4ca5-abc2-8166ed4240d46
352086Clarinex 5 MG Oral TabletSYc671342e-69a2-4ca5-abc2-8166ed4240d46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
78206-119-0178206011901100 TABLET, FILM COATED in 1 BOTTLE (78206-119-01) 2021-06-010000-00-00NoNoCurrent