Desloratadine

Product NDC
50090-3975
11-digit product format
500903975
Labeler code
50090
Product ID
50090-3975_435e054f-b898-4718-90d6-cfa9f98077f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desloratadine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078355
Marketing category
ANDA
Marketing start
2015-06-12
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
2026-12-31

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
50090-3975-0Desloratadine90 in 1 BOTTLETABLET908
50090-3975-1Desloratadine30 in 1 BOTTLETABLET308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3975-0EA - Each50090-397505a783f6-d753-4b17-9058-d612f383310f12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3975DESLORATADINE TABLET [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 2 package rows20231213_36307c2b-6b6a-46a9-9fe4-1798fc72e7b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349420desloratadine 5 MG Oral TabletPSN36307c2b-6b6a-46a9-9fe4-1798fc72e7b88
349420desloratadine 5 MG Oral TabletSCD36307c2b-6b6a-46a9-9fe4-1798fc72e7b88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3975-05009039750090 TABLET in 1 BOTTLE (50090-3975-0) 90 tablet2018-12-130000-00-00NoNoCurrent
50090-3975-15009039750130 TABLET in 1 BOTTLE (50090-3975-1) 30 tablet2018-12-060000-00-00NoNoCurrent