FDA.reportPublic FDA data

Desloratadine

Product NDC
69543-107
11-digit product format
695430107
Labeler code
69543
Product ID
69543-107_7c658c72-2694-49dd-9950-0aed03e3d7dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desloratadine
Dosage form
TABLET
Route
ORAL
Labeler
Virtus Pharmaceuticals, LLC
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
69543-107-10Desloratadine100 in 1 BOTTLE, PLASTICTABLET1007
69543-107-30Desloratadine30 in 1 BOTTLE, PLASTICTABLET307
69543-107-50Desloratadine500 in 1 BOTTLE, PLASTICTABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69543-107-10EA - Each69543-1075d8fa01e-bef1-46a0-872f-2f8f63953a6212015-08-04
69543-107-30EA - Each69543-10763262f3a-46f5-4f38-8f02-c08b834953a712015-08-04
69543-107-50EA - Each69543-107080f16f8-4286-411f-8289-cde5f650025912015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DesloratadineACTIVE INGREDIENTFVF865388RDESLORATADINE TABLET [VIRTUS PHARMACEUTICALS]2
DesloratadineACTIVE MOIETYFVF865388RDESLORATADINE TABLET [VIRTUS PHARMACEUTICALS]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDESLORATADINE TABLET [VIRTUS PHARMACEUTICALS]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48DESLORATADINE TABLET [VIRTUS PHARMACEUTICALS]2
FD&C blue no. 2INACTIVE INGREDIENTL06K8R7DQKDESLORATADINE TABLET [VIRTUS PHARMACEUTICALS]2
Starch, CornINACTIVE INGREDIENTO8232NY3SJDESLORATADINE TABLET [VIRTUS PHARMACEUTICALS]2
talcINACTIVE INGREDIENT7SEV7J4R1UDESLORATADINE TABLET [VIRTUS PHARMACEUTICALS]2
zinc stearateINACTIVE INGREDIENTH92E6QA4FVDESLORATADINE TABLET [VIRTUS PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69543-107DESLORATADINE TABLET [VIRTUS PHARMACEUTICALS]6Current NDC, Legacy NDC, 3 package rows20210410_0fe374d0-c14b-4102-b568-eb79165fc7ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349420desloratadine 5 MG Oral TabletPSNcf7f838b-4595-4c81-97b9-e1594347e1bd102
349420desloratadine 5 MG Oral TabletSCDcf7f838b-4595-4c81-97b9-e1594347e1bd102
349420desloratadine 5 MG Oral TabletPSN36307c2b-6b6a-46a9-9fe4-1798fc72e7b88
349420desloratadine 5 MG Oral TabletSCD36307c2b-6b6a-46a9-9fe4-1798fc72e7b88
349420desloratadine 5 MG Oral TabletPSN0fe374d0-c14b-4102-b568-eb79165fc7ef7
349420desloratadine 5 MG Oral TabletSCD0fe374d0-c14b-4102-b568-eb79165fc7ef7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69543-107-1069543010710100 TABLET in 1 BOTTLE, PLASTIC (69543-107-10) 100 tablet2015-06-120000-00-00NoNoCurrent
69543-107-306954301073030 in 1 BOTTLE, PLASTICHistorical
69543-107-5069543010750500 TABLET in 1 BOTTLE, PLASTIC (69543-107-50) 500 tablet2015-06-120000-00-00NoNoCurrent