FDA.reportPublic FDA data

DESLORATADINE

Product NDC
50090-4794
11-digit product format
500904794
Labeler code
50090
Product ID
50090-4794_e682431d-3333-4fcb-8457-38b3e045b723
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DESLORATADINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078352
Marketing category
ANDA
Marketing start
2013-02-25
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DESLORATADINE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESLORATADINE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFVF865388R
Rxcui349420

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
50090-4794-02023-02-07C16284748780-1f386c649-f47a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DESLORATADINE TABLETS safely and effectively. See full prescribing information for DESLORATADINE TABLETS. DESLORATADINE tablets for oral use Initial U.S. Approval: 2001
50090-4794-12023-02-07C16284748780-1f386c649-f47a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DESLORATADINE TABLETS safely and effectively. See full prescribing information for DESLORATADINE TABLETS. DESLORATADINE tablets for oral use Initial U.S. Approval: 2001
50090-4794-02023-01-30C16284748780-1f386c649-f47a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DESLORATADINE TABLETS safely and effectively. See full prescribing information for DESLORATADINE TABLETS. DESLORATADINE tablets for oral use Initial U.S. Approval: 2001
50090-4794-12023-01-30C16284748780-1f386c649-f47a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DESLORATADINE TABLETS 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
50090-4794-0DESLORATADINE90 in 1 BOTTLETABLET, FILM COATED9012
50090-4794-1DESLORATADINE30 in 1 BOTTLETABLET, FILM COATED3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4794-0EA - Each50090-47943c2a017e-c9fe-46d5-bcb1-58a9e57f302812025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349420desloratadine 5 MG Oral TabletPSN69b9635b-c790-4316-a790-67b0f5512b7212
349420desloratadine 5 MG Oral TabletSCD69b9635b-c790-4316-a790-67b0f5512b7212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4794-05009047940090 TABLET, FILM COATED in 1 BOTTLE (50090-4794-0) 2019-12-120000-00-00NoNoCurrent
50090-4794-15009047940130 TABLET, FILM COATED in 1 BOTTLE (50090-4794-1) 2019-12-120000-00-00NoNoCurrent