Clarinex

Product NDC
21695-815
11-digit product format
216950815
Labeler code
21695
Product ID
21695-815_b7b0b1a0-2ab3-4697-bee4-0cd7fd5088b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desloratadine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA021297
Marketing category
NDA
Marketing start
2002-02-08
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
E
Listing certified through
2017-12-31
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
21695-815-102019-09-24C16284748780-1934fe258-47be-48b1-e053-8cdaa90a720aCLARINEX ® (desloratadine) ® TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-815-10Clarinex10 in 1 BOTTLETABLET, FILM COATED101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-815-10EA - Each21695-815af0ff26e-f335-4093-bcb3-e9ba9c294c0b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DesloratadineACTIVE INGREDIENTFVF865388RCLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
DesloratadineACTIVE MOIETYFVF865388RCLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
dibasic calcium phosphate dihydrateINACTIVE INGREDIENTO7TSZ97GEPCLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ACLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
talcINACTIVE INGREDIENT7SEV7J4R1UCLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FCLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-815CLARINEX (DESLORATADINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110428_b7b0b1a0-2ab3-4697-bee4-0cd7fd5088b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
352086CLARINEX 5 MG Oral TabletPSNb7b0b1a0-2ab3-4697-bee4-0cd7fd5088b91
349420desloratadine 5 MG Oral TabletPSNb7b0b1a0-2ab3-4697-bee4-0cd7fd5088b91
352086desloratadine 5 MG Oral Tablet [Clarinex]SBDb7b0b1a0-2ab3-4697-bee4-0cd7fd5088b91
349420desloratadine 5 MG Oral TabletSCDb7b0b1a0-2ab3-4697-bee4-0cd7fd5088b91
352086Clarinex 5 MG Oral TabletSYb7b0b1a0-2ab3-4697-bee4-0cd7fd5088b91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-815-102169508151010 in 1 BOTTLEHistorical