FDA.reportPublic FDA data

Desloratadine

Product NDC
62756-523
11-digit product format
627560523
Labeler code
62756
Product ID
62756-523_b5875e34-88ab-4ffc-b9b2-7281ec549566
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desloratadine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA078359
Marketing category
ANDA
Marketing start
2010-11-24
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
2020-12-31
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
62756-523-082021-01-29C16284748780-1ba0f9c33-4fa9-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use DESLORATADINE safely and effectively. See full prescribing information for DESLORATADINE TABLETS. DESLORATADINE tablets for oral use Initial U.S. Approval: 2001
62756-523-132021-01-29C16284748780-1ba0f9c33-4fa9-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use DESLORATADINE safely and effectively. See full prescribing information for DESLORATADINE TABLETS. DESLORATADINE tablets for oral use Initial U.S. Approval: 2001
62756-523-182021-01-29C16284748780-1ba0f9c33-4fa9-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use DESLORATADINE safely and effectively. See full prescribing information for DESLORATADINE TABLETS. DESLORATADINE tablets for oral use Initial U.S. Approval: 2001
62756-523-832021-01-29C16284748780-1ba0f9c33-4fa9-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use DESLORATADINE safely and effectively. See full prescribing information for DESLORATADINE TABLETS. DESLORATADINE tablets for oral use Initial U.S. Approval: 2001
62756-523-882021-01-29C16284748780-1ba0f9c33-4fa9-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use DESLORATADINE safely and effectively. See full prescribing information for DESLORATADINE TABLETS. DESLORATADINE tablets for oral use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62756-523-08Desloratadine100 in 1 BOTTLETABLET, FILM COATED1008
62756-523-13Desloratadine500 in 1 BOTTLETABLET, FILM COATED5008
62756-523-18Desloratadine1000 in 1 BOTTLETABLET, FILM COATED10008
62756-523-83Desloratadine30 in 1 BOTTLETABLET, FILM COATED308
62756-523-88Desloratadine100 in 1 BOTTLETABLET, FILM COATED1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-523-13EA - Each62756-5230ca4dd9a-72cc-46c7-b3c9-003a918d956012013-02-13
62756-523-88EA - Each62756-523f26d77ba-d297-4ec0-ad5c-fab72c570edf12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DESLORATADINEACTIVE INGREDIENTFVF865388RDESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
DESLORATADINEACTIVE MOIETYFVF865388RDESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WDESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYDESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIDESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-523DESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]8Legacy NDC, 5 package rows20190508_58ba2dc8-10c2-4532-92e2-40ec2fee3378.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349420desloratadine 5 MG Oral TabletPSN58ba2dc8-10c2-4532-92e2-40ec2fee33788
349420desloratadine 5 MG Oral TabletSCD58ba2dc8-10c2-4532-92e2-40ec2fee33788

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
62756-523-0862756052308100 in 1 BOTTLEHistorical
62756-523-1362756052313500 in 1 BOTTLEHistorical
62756-523-18627560523181000 in 1 BOTTLEHistorical
62756-523-836275605238330 in 1 BOTTLEHistorical
62756-523-8862756052388100 in 1 BOTTLEHistorical