DESLORATADINE

Product NDC
71335-1000
11-digit product format
713351000
Labeler code
71335
Product ID
71335-1000_6ceb6a60-c6de-4829-b838-2b9cabfee225
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DESLORATADINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2026-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1000-1DESLORATADINE30 in 1 BOTTLETABLET, FILM COATED304
71335-1000-2DESLORATADINE90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1000DESLORATADINE TABLET, FILM COATED [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 2 package rows20240410_f84c8de3-a7d3-4e8b-bfb6-04259e79450a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1000-17133510000130 TABLET, FILM COATED in 1 BOTTLE (71335-1000-1) 2018-11-130000-00-00NoNoCurrent
71335-1000-27133510000290 TABLET, FILM COATED in 1 BOTTLE (71335-1000-2) 2024-04-090000-00-00NoNoCurrent